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Express Scripts to Market $1M Genetic Pill

Express Scripts Holding Co built a multi-billion enterprise pressuring drug companies to lower their prices for U.S. patients. Now it is quietly building a side business: getting paid to help drug companies dispense a new generation of high-priced drugs.

Chief Medical Officer Steve Miller told Reuters in an interview that Express Scripts is in talks with biotechnology companies Biomarin Pharmaceutical Inc, Spark Therapeutics Inc and Bluebird Bio Inc to have its specialty pharmaceutical business exclusively distribute their new hemophilia therapies when they are expected to become available in 2019 and 2020,.

Biomarin, Spark and Bluebird confirmed to Reuters that they were speaking to a payers – a group generally defined as pharmacy benefit managers, health plans and government agencies. Analysts project those drugs could top $1 million to $1.5 million in price.

Rather than rail against the drugs’ expected high prices, Miller echoes the familiar drug company argument that the potentially curative therapies will likely be worth the high cost if they supplant the hundreds of thousands of dollars in annual medical costs to treat ailments such as hemophilia, which affects about 20,000 people in the United States alone.

“Even if they charge $1 million, that’s a great deal,” Miller said. “So there are going to be some gene therapies where it is very clear that everyone who has that disease should get it.”

By working closely with biotech companies, Miller says it can help their expensive therapies succeed commercially. To manage any potential conflicts of interest, he said Express Scripts separates its benefits management and specialty pharmacy businesses.

The move into hemophilia builds on exclusive rights Express Scripts already has to distribute Spark’s Luxturna – an $850,000 treatment for a rare genetic disorder that, left untreated, causes children to go blind. It has a similar deal with Biogen Inc (BIIB.O) on Spinraza, he told Reuters. The drug costs $750,000 the first year and treats the rare condition spinal muscular atrophy that often kills babies within months of their birth. Spark and Biogen confirmed the agreements.

The company also helps manage one of the most expensive gene-based cancer treatments on the market: the $475,000 Novartis AG gene-based cancer therapy Kymriah – a personalized treatment that requires a long hospital stay. Novartis confirmed the arrangement to Reuters.

Those deals put Express Scripts in a vastly different role than its traditional business managing prescription drug claims for the employees of its corporate and government clients, a business Cigna Corp (CI.N) found so valuable that it agreed in March to acquire Express Scripts for $52 billion.

Express Scripts has been expanding its low-profile specialty pharmacy business – which dispenses drugs that usually aren’t sold through drugstores because they require special handling. By using its own pharmacy instead of outsiders, Express Scripts is able to hold onto more of the profits along the drug distribution chain.

Specialty pharmacy is one of Express Script’s fastest growing businesses and accounts for about a third of its sales and profits, ISI Evercore analyst Ross Muken said. The company earned $4.1 billion last year on total revenue of more than $100 billion – it does not break out financial information for specialty pharmacy.

Many of the newest, most advanced medicines – including gene-based therapies and personalized cancer treatments – will be dispensed through specialty pharmacies, and Express Scripts is pitching biotech companies for exclusive arrangements.

WCAB Invalidates AD Dispute Resolution Regulation

Anthony Dennis sustained an industrial injury to his right wrist on October 29, 2013 while working as an inmate laborer for the California Department of Corrections and Rehabilitation. His claim settled via Stipulation and Award for 31 % permanent disability on September 11, 2017.

Prior to the settlement, on May 15, 2017 the Department of Corrections sent a Notice of Offer of Modified Work stating that applicant had voluntarily terminated his employment since he had been released from prison after .the injury occurred. Dennis disputed the offer of work and requested a dispute resolution before the Administrative Director on September 19, 2017.

The parties never received a response from the AD. Thus Dennis filed a DOR to address the matter on February 5, 2018 as well as a “Petition for Grant of Supplemental Job Displacement Benefit.”

Defendant claimed at trial that if applicant’s DOR/Appeal of the Administrative Directors presumed denial was not timely. The WCJ found that it was not and thus, the ADs determination ( denial) was final, and denied the Petition for the SJDB Benefit.

Dennis filed for Reconsideration of this finding and also arguing that he is eligible to the voucher. The WCAB granted the Petition and ordered that he be provided with a SJDB Voucher in the case of Dennis v. California Department of Corrections and Rehabilitation.

The parties never received a finding from the Administrative Director; therefore the request was deemed denied on December 8, 2017 pursuant to 17 8 CCR 10133.54(±). An appeal of the denial was to be filed by December 28, 2017 per 8 CCR 10133.54(g).

Applicant filed his Petition for Grant of Supplemental Job Displacement Benefit on February 5, 2018, well after the time allotted per the regulations. 8 CCR 10133.54(g) states “Either party may appeal the determination of the administrative director by filing a written petition together with a declaration of readiness to proceed pursuant to section 10250 within twenty days after a request is deemed denied” .

The WCJ found that applicant is barred from SJDB because applicant failed to timely appeal the Administrative Director’s presumed denial of his request.

However, section 5300 statutorily vests the Appeals Board with the exclusive jurisdiction to adjudicate claims regarding the “recovery of compensation, or concerning any right or liability arising out of or incidental thereto” of injuries that “arise out of and in the course” of employment This exclusive jurisdiction extends to inmates who sustained injury arising out of and in the course of assigned employment. (§ 3370.)

Furthermore, section 4658.7(h) does nqt abrogate the Appeals Board ability to adjudicate disputes that arise under this subdivision. Section 4658.7(h) limits the Administrative Director to adopting regulations “for the administration of this section” and does not extent the Administrative Director’s authority to adjudicate SJDB disputes.

Thus, irrespective of Rule 10133.54, the Appeals Board maintains exclusive jurisdiction, to adjudicate the issue of whether applicant is entitled to the benefits under the SJDB program.

While defendant timely sent applicant a Notice offering regular, modified, or alternative work, such offer was not a bona fide job offer because applicant was released from prison and could not return to prison for employment.

This decision may have further implications in terms of other dispute resolution functions of the AD, such as IMR.  

AI Accurately Diagnoses 50 Eye Conditions

London-based DeepMind, owned by Google’s parent company, Alphabet, focuses heavily on the specifics of using artificial intelligence in health care, and on Monday it released a study showing the progress it’s made in using AI to diagnose eye conditions.

Published in the science journal Nature Medicine, the study reports that DeepMind, in partnership with Moorfields Eye Hospital in London, has trained its algorithms to detect over 50 sight-threatening conditions to the same accuracy as expert clinicians. It’s also capable of correctly recommending the most appropriate course of action for patients and prioritize those in most urgent need of care.

In a project that began two years ago, DeepMind trained its machine learning algorithms using thousands of historic and fully anonymized eye scans to identify diseases that could lead to sight loss. According to the study, the system can now do so with 94 percent accuracy, and the hope is that it could eventually be used to transform how eye exams are conducted around the world.

AI is taking on a number of roles within health care more widely. In June, Babylon Health said that it gave its artificial intelligence technology the same test required of would-be general practitioners in Britain and that the AI performed better than humans. In March, researchers found that machine learning can classify heart anatomy on an ultrasound scan better than a human. AI is also being used to help emergency call dispatchers in Europe detect heart attack situations.

Diagnosing eye diseases from ocular scans is a complex and time-consuming for doctors. Also, an aging global population means eye disease is becoming more prevalent, increasing the burden on healthcare systems. That’s providing the opportunity for AI to pitch in.

“The number of eye scans we’re performing is growing at a pace much faster than human experts are able to interpret them,” said Pearse Keane, consultant ophthalmologist at Moorfields, in a statement. “There is a risk that this may cause delays in the diagnosis and treatment of sight-threatening diseases, which can be devastating for patients.”

Using AI instead could mean earlier diagnoses for patients and therefore earlier treatment, leading to less deterioration in eyesight down the line. “It gives us the best chance of saving people’s sight,” said Keane.

DeepMind’s AI has been trained using one particular type of eye scanner, but researchers say it’s compatible with any model. Not only does this mean it can be used widely and without hardware restrictions, but that it will remain useful in the future even when equipment is replaced and updated.

The AI can also explain to doctors how it arrived at a particular decision, which will allow the doctors to scrutinize whether it’s made the right call before going ahead with treatment.

Before the AI can be used in hospitals to diagnose real patients it must now go through clinical trials and gain regulatory approval.

August 13, 2018 Edition


Rene Thomas Folse, JD, Ph.D. is the host for this edition which reports on the following news stories: WCAB Adds Instead of Combining PD Ratings, Unlicensed Tree Trimmer v. Homeowner Suit Affirmed, Feds Join 4 Whistleblower Opiate Cases, Illegal Fentanyl Floods California Border, Indicted Owner of Sham Clinics Faces Immigration Charges, 14 California Hospitals Settle Fraud Claims for $65M, WCIRB Proposes 4.5% Rate Reduction, Second WCAB Appointment Has No WC Experience, FDA Rejects Another New Opioid, Another $2B Health Insurance/Pharmacy Merger.

Jury Awards $289M to Injured Groundskeeper

Chemical giant Monsanto has been ordered to pay $289m in compensatory and punitive damages to a man who claimed herbicides containing glyphosate had caused his cancer. In a landmark case, a Californian jury found that Monsanto knew its Roundup and RangerPro weedkillers were dangerous and failed to warn consumers. It’s the first lawsuit to go to trial alleging a glyphosate link to cancer.

Monsanto denies that glyphosate causes cancer and says it intends to appeal against the ruling. “The jury got it wrong,” vice-president Scott Partridge said outside the courthouse in San Francisco.

Groundskeeper Dewayne Johnson was diagnosed with non-Hodgkin’s lymphoma in 2014. His lawyers said he regularly used a form of RangerPro while working at a school in Benicia, California. He is among more than 5,000 similar plaintiffs across the US. The California ruling is likely to lead to hundreds of other claims against Monsanto, which was recently bought by the German conglomerate Bayer AG.

Following an eight-week trial, jurors found that the company had acted with “malice” and that its weedkillers contributed “substantially” to Mr Johnson’s terminal illness. Mr Johnson’s lawyer, Brent Wisner, said the jury’s verdict showed that the evidence against the product was “overwhelming.”

The company disagreed. “Today’s decision does not change the fact that more than 800 scientific studies and reviews – and conclusions by the US Environmental Protection Agency, the US National Institutes of Health and regulatory authorities around the world – support the fact that glyphosate does not cause cancer, and did not cause Mr Johnson’s cancer,”

Glyphosate is the world’s most common weedkiller and the science about its safety is still far from settled.

In 2015 the International Agency for Research on Cancer, the World Health Organization’s cancer agency, concluded that it was “probably carcinogenic to humans”. but the US Environmental Protection Agency (EPA) continues to insist that glyphosate is safe when used carefully.

Campaigners question how the EPA assessment was reached, citing evidence of what they say was inappropriate industry involvement in the decision. Some Democrats have even called for a Department of Justice investigation into alleged collusion between government officials and Monsanto.

In California, where a judge recently ruled that coffee must carry a cancer warning, the agriculture industry sued to prevent such a label for glyphosate even though the state lists it as a chemical known to cause cancer.

In Europe the battle over glyphosate has been fierce. French President Emmanuel Macron is trying to ban it despite the resistance of some French lawmakers and the fact that the European Commission recently granted the weedkiller another five-year licence.

The evidence used in the case will likely be used to support industrial injury claims by California workers’ who have had work related exposure to glyphosate and suffer health consequences.

MRI Scans – Maybe Not So Safe After All

Gadolinium contrast media are chemical substances used in magnetic resonance imaging (MRI) scans. When injected into the body, gadolinium contrast medium enhances and improves the quality of the MRI images. It is used in about 1 in 3 of MRI scans

Three MRI contrast agents have been approved for clinical use in the United States as of 1994. Six more MRI contrast agents were approved by FDA for clinical use from 1995 through 2017.

Radiologists and patients began to question the safety of gadolinium a few years ago when a study came out in late 2014 showing the agent is deposited and retained in the brain.This, combined with a small percentage of patients who claim their health was harmed following gadolinium exams, has sparked a big debate in radiology over the safety of these agents.

There are numerous patient-created groups on social media that discuss MRI gadolinium toxicity issues, which have raise public awareness on the topic of possible connections with previously unknown gadolinium side effects.

The biggest public relations boost for these patients came in November 2017 when action movie actor Chuck Norris filed a lawsuit against a contrast vendor and the contrast distributor for allegedly poisoning his wife Gena. She had several contrast MRI exams and the suit alleges numerous adverse health effects began after these exams. Norris is seeking $10 million in damage.

The suit alleges she contracted what is being called “gadolinium deposition disease.” It is a term often used by patients who claim they now have chronic health problems from their contrast MRI exams. However, the term is not accepted by many in the medical community because of the lack of scientific evidence showing a direct connection with the contrast agents.

The lawsuit described Gena’s symptoms as burning pain throughout her body, violent shaking, numbness, tingling, weakness, cognitive deficits, kidney damage and trouble breathing. These symptoms are similar to others often reported in patient social media groups.

The FDA stated there is no clinical evidence that directly links gadolinium retention to adverse health effects in patients with normal kidney function, and the FDA has concluded that the benefit of all approved GBCAs continues to outweigh any potential risks.

However, in July 2017, the European Medicines Agency (EMA) issued a final opinion that recommended restricting the use of some linear gadolinium-based contrast agents (GBCAs) and suspending the marketing authorizations of others, citing concerns about gadolinium deposition.

Patients that say they were harmed by gadolinium agents often argue they were never given any sort of informed consent documents to sign warning them of gadolinium’s potential hazards. Experts speaking at Radiological Society of North America (RSNA) 2017 said this might be easier said than done.

Worker’s Compensation Claims Administrators need to be aware of these risks, which may cause a compensable consequence injury to an injured worker. Utilization Review vendors should carefully review a RFA for a contrast study, and consider safer alternatives when they are available.

Some MRI vendors have touted new technologies like black blood imaging, or new protocols that can reduce or eliminate the need for MRI contrast. However, some types of exams still require the use of gadolinium in order to answer the clinical questions the MRI is supposed to answer. There is ongoing research to find alternatives, but currently there is no good alternative for all the things that the gadolinium can help with.

Feds Join 4 Whistleblower Opiate Cases

The U.S. Justice Department has joined several whistleblower lawsuits against Indivior Plc and Reckitt Benckiser Group PLC, alleging that the drugmakers improperly marketed the opioid addiction treatment Suboxone.

The Justice Department in filings last week in federal court in Abingdon, Virginia, said it was intervening in four separate whistleblower lawsuits related to the Britain-based companies’ marketing of Suboxone and the related drug Subutex.

According to Reuters, the action came after Indivior, which was spun out of Reckitt in 2014, said last month it was in “advanced discussions” with the Justice Department to resolve an investigation dating back to 2013 related to its marketing practices.

Indivior said it has set aside $438 million to cover legal matters, most of which relates to the investigation. Reckitt has separately reserved 303 million pounds ($390 million) in connection with the investigation.

“We have been cooperating with the DOJ in its investigation for several years, and we remain in advanced discussions about a possible resolution that would render any suit by the department unnecessary,” Indivior said in a statement.

Reckitt spokeswoman Patty O’Hayer said on Wednesday that the company “will be presenting our case to the DOJ in the appropriate channels to defend the actions that we believe that we have taken.”

The Justice Department declined to comment.

The lawsuits were filed under the False Claims Act, which allows whistleblowers to sue companies on the government’s behalf. The government may intervene in the cases, which is typically a major boost for them.

Among the complaints unsealed on Aug. 2 was one filed by former Reckitt employee Ann Marie Williams.

Her 2013 lawsuit alleged the companies marketed unapproved dosages and uses of Suboxone and Subutex and claimed Reckitt made misleading claims to the U.S. Food and Drug Administration to obtain approval for a dissolvable film version of Suboxone.

The lawsuit claimed that as a period of marketing exclusivity granted by the FDA for the tablet form of Suboxone was coming to an end, Reckitt sought U.S. approval of a new patent-protected dissolvable strip version of the drug, which it claimed would be safer and less susceptible to abuse.

But the lawsuit alleges that the film version was inferior to the tablets as it could be more easily diverted for improper purposes and posed an increased risk to children who could accidentally put it in their mouths.

The companies marketed the Suboxone film as “safer” for patients and children than tablets, the lawsuit said.

The case is U.S. ex rel. Williams v. Reckitt Benckiser Inc, et al, U.S. District Court, Western District of Virginia, No. 13-cv-00036.

Another $2B Health Insurance/Pharmacy Merger

UnitedHealth Group is poised to grow its presence in the mental health sector if it closes a yet-to-be-confirmed deal for pharmacy operator Genoa Health.

This “convergence of retail, pharmacy and health insurance,” as former Blue Cross and Blue Shield of Minnesota CEO Michael Guyette put it to Twin City Business in an interview this April, has become an emerging trend in the marketplace.

While not formally announced, a source familiar with the deal told Axios that a tentative agreement had been reached.

Genoa, a Washington-state based company, operates 400 pharmacies across the country – all of which deal with patients with behavioral or other complex, chronic health issues.

Axios said that with Genoa under its belt, the Minnetonka-based Fortune 500 company UnitedHealth Group would control the specialty channel.

Axios didn’t offer a sale figure, but Bloomberg reported Tuesday that if Genoa sold, it could fetch a price of more than $2 billion. Bloomberg also noted Walgreens as a potential buyer.

The prospect of a UnitedHealth Group-Genoa deal follows an agreement reached late last year involving CVS buying Aetna for $69 billion, though the merger is still pending. Meanwhile, Amazon recently acquired prescription delivery startup PillPack Inc.

For localized healthcare entities, Guyette suggested this trend means a need to adjust to the changes to stay competitive, like by launching strategic partnerships.

Axios was told that after the sale to UnitedHealth Group, Genoa CEO John Figueroa would move on and Genoa chief commercial officer Mark Peterson would step in to run Genoa under UnitedHealth.

None of the parties involved in the potential deal, however, have yet commented.

Illegal Fentanyl Floods California Border

Illicit use of pharmaceutical fentanyl and its analogues first appeared in the mid-1970s in the medical community and continues in the present.

More than 12 different analogues of fentanyl, all unapproved and clandestinely-produced, have been identified in the U.S. drug traffic. The biological effects of the fentanyl analogues are similar to those of heroin, with the exception that many users report a noticeably less euphoric high associated with the drug and stronger sedative and analgesic effects.

Fentanyl analogues may be hundreds of times more potent than heroin.

Non-medical use of fentanyl by individuals without opiate tolerance can be very dangerous and has resulted in numerous deaths. Even those with opiate tolerances are at high risk for overdoses.

And fentanyl is regularly being smuggled into California.

This month 20 year old Flavio Diego Rivera Davalos, was sentenced to 87 months in custody based on his guilty plea admitting that he smuggled approximately 77 pounds of fentanyl into the United States.

Davalos, who was 19 at the time of the offense, was arrested at the San Ysidro Port of Entry on December 8, 2017 following one of the largest seizures of the deadly opioid along the Southwest border.

According to expert opinions included in court records, 77 pounds of fentanyl would yield 800,000 potentially fatal dosage units and a market value of more than $2 million.

And also this August, Fernando Jesus Peraza, a U.S. citizen living in Tijuana, was arraigned in federal court on charges of importing over 20,000 fentanyl pills in what is believed to be the largest seizure of fentanyl in pill form along the U.S.-Mexico border.

Peraza, who works in San Diego County, was arrested early August 9, at the San Ysidro Port of Entry

Peraza was the driver, registered owner and sole occupant of the vehicle. U.S. Custom Border & Protection officers initially contacted Peraza in preprimary inspection area but was then referred to secondary inspection, where officers found four packages concealed in the passenger side rear quarter panel. The pills tested positive for fentanyl but were designed to resemble M30s, or oxycodone.

Earlier this month, Cristian Araujo Aguirre, 19 of Tijuana, was charged with importing 11,490 fentanyl pills, 61 pounds of methamphetamine and 14 pounds of heroin.

Aguirre was arrested at the San Ysidro Port of Entry on August 1, 2018. Aguirre is currently detained. His next court appearance is on August 31, 2018.

“This is the biggest fentanyl pill seizure we’ve seen along the Southwest Border, and it’s likely a national record,” said U.S. Attorney Adam Braverman.

August is only 9 days old. The “national record” may be broken (again) before the end of the month.

WCIRB Proposes 4.5% Rate Reduction

The WCIRB Governing Committee voted to authorize the WCIRB to submit a January 1, 2019 Advisory Pure Premium Rate Filing to the California Insurance Commissioner.

The Filing will propose advisory pure premium rates that average $1.70 per $100 of payroll, which is 4.5% less than the average approved July 1, 2018 advisory pure premium rate of $1.78 and 20% less than the industry average filed pure premium rate of $2.13 as of July 1, 2018.

If adopted, this would be the eighth consecutive pure premium rate decrease since 2015 totaling approximately 40%.

In his presentation to the Governing Committee, WCIRB EVP and Chief Actuary Dave Bellusci noted that the indicated January 1, 2019 average advisory pure premium reflects continued downward loss development, acceleration in claim settlements, sharply declining pharmaceutical costs and decline in the number of liens being filed.

Despite these continued favorable trends, Mr. Bellusci cautioned that allocated loss adjustment expenses continue to increase and that the medical savings driving these advisory pure premium rate decreases could erode if medical inflation rates were to return to levels closer to historical norms.

The WCIRB will submit its January 1, 2019 Advisory Pure Premium Rate Filing to the California Department of Insurance (CDI) on or around August 21, 2018.

The CDI will schedule a public hearing to consider the Filing and once the Notice of Proposed Action and Notice of Public Hearing is issued, the WCIRB will post a copy in the Filings and Plans section of the WCIRB website.