ICER Weekly View 11-30-18

From the desk of Mitchell Stein


Good morning. Only Nixon could go to China, and only Kirk could make peace with the Klingons. Does that mean only a Republican can reform Medicare drug pricing? If the current Administration’s proposals move forward, that will be the relevant correlation (although it goes without saying that we won’t assign causation). We’ll take a look at the Administration’s proposal to do just that; we’ll also catch-up on everything else that happened while we were gone. Here’s the full line-up for this week:

ICER in the News – Draft scoping document on immune tolerance, new VP of Development appointed, Reuters looks at ICER/Novartis pricing, Novartis CEO on ICER/pricing, Axios on ICER, Luxtruna approval coverage includes ICER, Kaiser’s bill of the month is MS drug ICER reviewed, ICER’s asthma work, Health Affairs asks will value pricing lead to patient access

Inside the Beltway – Administration Part D proposal (multiple stories), Grassley to replace Hatch on FInance, Trump/Sanders drug pricing mind meld, a possible future for the CREATES Act, PhRMA lobbying increases 126%

Industry Trends – GoodRx drug cost survey, CVS-Aetna deal closes (probably), Walgreens-Humana snuggle up, price hikes from Pfizer/Merck, FDA approvals can be both good and bad, peanut allergy treatment, EpiPen generic not such a bargain, second mutation-specific drug approval

Now, on to the news.

ICER in the News

ICER has posted a Draft Scoping Document outlining a planned review of the comparative clinical effectiveness and value of treatments for peanut allergy. This evidence review will examine two new technologies to induce immune tolerance – Viaskin Peanut (DBV Technologies) and AR101 (Aimmune Therapeutics) – as well as non-commercialized oral immunotherapy (OIT). On June 11, 2019, ICER’s report will be the subject of a meeting of the California Technology Assessment Forum. The release was covered by and thepharmaletter.

Institute for Clinical and Economic Review Posts Draft Scoping Document for the Assessment of Treatments for Peanut Allergy

ICER has appointed Athelia “Tia” Tilson as the organization’s first Vice President of Development. Ms. Tilson will lead ICER’s fundraising efforts, connecting philanthropic donors to ICER’s core mission of helping all patients achieve sustainable access to high-value care.

ICER Appoints Athelia “Tia” Tilson as Vice President of Development

Pegged to Novartis suggesting that a $4-5 million price for its gene therapy would be fair value, Reuters took an in-depth look at ICER’s ongoing review of treatments for spinal muscular atrophy.

U.S. benefits manager baulks after Novartis values gene therapy at…

ZURICH (Reuters) – Just weeks after Novartis floated the idea that $4-5 million was fair value for its new gene therapy against a deadly neuromuscular disease, a major benefits manager is pushing back.

Writing on, the CEO of Novartis discusses gene therapy pricing, including ICER’s work.

Novartis CEO: 4 factors can help the industry price and pay for lifesaving cell and gene therapies

The health-care industry is entering a new era in medicine with the emergence of potentially curative cell and gene therapies. Novartis CEO Vas Narasimhan says there is a fundamental challenge: how to pay for these therapies and make them available to patients in need.

Axios looks at how a drug’s value is defined in other countries, as well as ICER’s role here in the US.

Defining a drug’s value

Luxturna was approved by the European Union. Several stories on the approval discuss ICER’s assessment of the drug based on US pricing. In addition to the Reuters story below, there were articles in BioPharmaDive and PMLive.

Novartis’s pricing might be tested with costly eye therapy

ZURICH (Reuters) – Novartis’s price-setting muscle is about to be tested after it won European Union approval for a blindness-fighting gene therapy whose $850,000 list cost in the United States has been labeled too expensive by some groups.

Kaiser Health News has been running a “bill of the month” feature on health care costs. This month they look at a bill for an MS drug and refer to ICER’s work on the drug class.

Chronically Ill, Traumatically Billed: The $123,000 Medicine For MS

Shereese Hickson’s doctor wanted her to try the infusion drug Ocrevus for her multiple sclerosis. Even though Hickson is trained as a medical billing coder, she was shocked to see two doses of the drug priced at $123,019, with her share set at $3,620.

MedPage Today looks at ICER’s recent report on asthma drugs.

Clinical Challenges: Do Asthma Biologic Benefits Justify High Cost?

With the approval of dupilumab (Dupixent) in late October, there are now five biologic therapies available for the treatment of severe asthma that is not controlled by standard treatments. The therapies have been hailed as game changers for severe asthma patients with either the allergic or type 2 inflammatory disease, who previously had few treatment options.

James Robinson, Director of the Berkeley Center for Health Technology, looks at Repatha’s price cut and asks if it will lead to increased access for patients. The piece includes a discussion of how ICER’s work has been used to make the PCSK9 inhibitors more affordable in the US.

Amgen Cuts Repatha’s Price By 60 Percent. Will Value-Based Pricing Support Value-based Patient Access?

Amgen and Regeneron/Sanofi now have reduced the net price of PCSK9 inhibitors towards ICER’s value-based benchmarks. If value-based prices of this sort are to be sustained, they need to be accompanied by value-based patient access. Access begins with the removal of onerous prior authorization and cost sharing obstacles but extends to active support for appropriate prescription and adherence.

Pharmaceutical News

Inside the Beltway/State Regulatory Developments

Earlier this week, the Trump Administration introduced a series of strategies to lower drug prices in Medicare Part D. Of particular note is the attempt to change the way “protected classes” are handled. Those classes have been untouchable since inception, despite agreement that their existence resulted in increased costs. As I alluded to in my intro, it may take a Republican to alter how those classes are handled. Although even in this case, opposition is already rising. For your reading pleasure, I selected four articles on the topic. First, from Weekly View favorite and Midwest CEPAC member Rachel Sachs, a Health Affairs blog describing the proposal and possible implications. Then, from Paige Winfield Cunningham of the Washington Post, a discussion of how patient groups are opposed because it limits patient choice, and finally two stories from The Hill a look at how 55 conservative groups have joined together in opposition and a report on a meeting of Republican lawmakers with Azar expressing their displeasure at the proposal. 

Administration Proposes Strategies To Lower Pharmaceutical Prices In Medicare Part D

It is heartening to see the administration finally turning its focus to Part D drug pricing, as it has focused largely on Part B to date. Some of these proposals, particularly the e-prescribing tool making out-of-pocket cost information available to providers at the point of prescription, are long overdue.

The Health 202: Trump’s latest move to lower drug spending pits patients versus insurers

Patient advocates and health insurers are pitted against each other in the Trump administration’s latest move to lower drug costs. The two groups disagree sharply over a proposal to allow Medicare insurers to stop covering certain drugs.

Conservative groups write letter opposing Trump move to lower drug prices

A coalition of 55 conservative groups has written a letter calling on the Trump administration to withdraw a proposal to lower drug prices, warning of creating “price controls.”

GOP lawmakers air concerns with Trump drug pricing move in meeting with health chief

Republican lawmakers who worked as doctors expressed their concerns about President Trump Donald John Trump Migrants stage hunger strike at Mexican border Top White House China hawk at G-20 summit after reports he would not attend CNN’s Gloria Borger: Source close to Cohen says he has ‘the goods’ MORE ‘s controversial proposal to lower drug prices with the president’s health chief Thursday.

The Hill reports that the drug industry is nervous over Grassley replacing Hatch as Chair of the Finance Committee.

Drug industry nervous about Grassley’s new role

Grassley, who wielded the Finance Committee gavel from 2003 to 2007, has taken a much more antagonistic approach to drug companies and is well known in Washington as a dogged investigator. “He has a history of being unafraid to flip over rocks,” said Rodney Whitlock, a consultant at ML Strategies who previously worked for Grassley as acting health policy director for the Finance Committee.

Politico explores the similarities between Donald Trump’s and Bernie Sanders’ drug pricing proposals.

The Bernie Sanders-Trump mind meld on drug costs

Sen. Bernie Sanders and Donald Trump are on the same page on drug pricing onceagain. A bill released Tuesday morning by Sanders (I-Vt.) and Rep. Ro Khanna (D-Calif.) to reduce U.S. drug prices takes a cue from the president’s recent proposal to reduce Medicare drug costs – both proposals seek to lower U.S.

Some think the election results bode well for the CREATES Act passage – only time will tell (BioPharma Dive).

CREATES Act looks likely to pass in Congress, policy analyst predicts

With drug pricing reform top of mind in Washington, Congress is likely to pass the CREATES Act within the next four months, one policy analyst predicted Wednesday, citing bipartisan backing. The bill would create a speedier and stronger legal process for generic manufacturers to challenge branded drugmakers that they claim are withholding drug samples in order to obstruct generic competition.

Axios takes a look at PhRMA spending. Among the findings, federal and state lobbying increased 126% in 2017.

PhRMA spends money on conservative think tanks, political groups and patient advocates

PhRMA’s lobbying and ad expenses skyrocketed last year.

Industry Trends

Drug costs still a problem for many according to a GoodRx survey, as reported by BioPharma Dive.

Drug costs pushed one-third of Americans to skip a prescription in the past year: GoodRx

One-third of Americans didn’t fill at least one of their prescriptions over the past year because of drug costs, according to results from a survey recently conducted by GoodRx, a company that aggregates and analyzes drug pricing data. Nearly all the survey respondents said they had some kind of health insurance, yet 42% noted they were still having difficulty paying for medications.

The CVS-Aetna deal has closed (HealthCare Dive) probably (Reuters).

CVS-Aetna megamerger finalized

​The $78 billion (including debt assumption) vertical megamerger of CVS and Aetna is official, combining the retail pharmacy powerhouse with Aetna’s health insurance business to create a mammoth healthcare entity with annual revenue of over $245 billion. Aetna will continue to operate as a standalone business under the umbrella of CVS Health.

U.S. judge raises prospect of not approving CVS-Aetna deal

WASHINGTON (Reuters) – In an unusual move on Thursday, a federal judge raised the prospect of not approving CVS Health Corp’s () deal to buy insurer Aetna Inc (), which closed earlier this week, during a routine portion of the legal process. Judge Richard Leon of the U.S.

Meanwhile, Walgreens and Humana are snuggling up together to fight off the isolation brought about by early snow, not to mention the merger mania spanning the PBM/insurer industries (Reuters).

Walgreens, Humana in talks to take stakes in each other: WSJ

Drugstore owner Walgreens Boots Alliance Inc and health insurer Humana Inc are in preliminary discussions to take equity stakes in each other, the Wall Street Journal reported on Tuesday, citing people familiar with the matter.

Pfizer announces price hikes to 10% of its portfolio that will take effect in January. As Endpoints News points out, what in previous years would have been viewed as moderation, this year’s move may result in much more drama. In the wake of Pfizer’s announcement, Merck also announced price increases for several drugs (Reuters).

Pfizer preps a laundry list of drug price hikes for the New Year – let the political fireworks begin

Pfizer is billing this as a restrained and completely reasonable move, but the pharma giant has just thrown down a gauntlet begging President Donald Trump to pick it up. On Friday afternoon the pharma giant $PFE put out a statement saying that it’s holding the price line on 90% of

Merck raised prices five drugs including Keytruda in November

NEW YORK (Reuters) – Merck & Co Inc said on Wednesday it raised U.S. prices on five of its drugs earlier in November by between 1.5 percent and 6 percent, including its top-selling cancer treatment Keytruda. The list price increases are the first that the U.S.

A long but fascinating read; it has everything, sex, murder, intrigue. OK, it has none of those things, but it is a great case study of how complicated health care can be. A compound has been known for years to treat a rare disease but was never approved by the FDA. A company ends up with a modified compound (doesn’t need refrigeration) and goes through clinical trials and the approval process. Now patients are concerned their costs will skyrocket. On the one hand, patients were being treated for little or no cost, on the other hand, the company went to the expense of the approval process and clinical trials. We’ll know more about how this plays out in December when the new pricing is announced but announce. Stay tuned.

An FDA approval could come at a major cost for patients

V ickie Moored can walk again. Her words don’t slur, her vision isn’t blurred, and she no longer collapses every day. The 65-year-old from Elkton, Va., says she has her life back, thanks to the stunning efficacy of a cheap, but unapproved, chemical called 3,4-DAP.

BioPharma Dive reports on the pluses and minuses of the potential peanut allergy treatment. One of the minuses, it won’t cost just peanuts… (you didn’t think I was going to be able to resist that one, did you?)

Aimmune’s peanut allergy drug draws mixed reactions

A clinical study of peanut allergy patients found a significantly higher proportion could ingest 600 mg or more of peanut protein after taking an investigational medicine from Aimmune Therapeutics compared to those on placebo, according to data published Sunday in the New England Journal of Medicine.

And speaking of allergic responses, remember that generic EpiPen? STAT’s Ed Silverman reports it is not the “low-cost” option that was expected.

FDA promised a ‘lower-cost option’ to EpiPen, but the price isn’t any lower – STAT

F ile this under “When is a bargain not really a bargain?” Three months ago, the Food and Drug Administration approved a generic version of the EpiPen allergy-relief device and made a point of noting the new product from Teva Pharmaceutical ( TEVA) would offer a “lower-cost option.”

For only the second time, the FDA approved a drug based on a mutation, not the location of the tumor (Washington Post). While the drug is not cheap, the manufacturer announced a money-back guarantee if the patent has not responded in 90 days (second article below, Fiercepharma).

FDA approves ‘precision medicine’ drug for different cancers with same mutation

November 26 The Food and Drug Administration on Monday approved a drug for a wide range of cancers based on a shared mutation, rather than the tumors’ locations – an advance for the sometimes controversial field of “precision medicine.”

‘Tissue agnostic’ cancer drug from Bayer, Loxo comes with high price, money-back guarantee

Bayer and its partner Loxo Oncology picked up FDA approval for their novel TRK inhibitor to treat certain patients whose tumors feature a neurotrophic receptor tyrosine kinase gene fusion. The drug will carry a list price of nearly $400,000 per year. 
@mhstein  |

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