Radar on Specialty Pharmacy

The administration continued its push to reduce drug spending with a Sept. 13 executive order focused on Medicare Part B and Part D. While previous efforts had focused on Part B, including an International Pricing Index (IPI) model, Part D had not previously been targeted. Many industry insiders view the moves as simply an effort by President Donald Trump to sway voters in his favor in the Nov. 3 election. And multiple questions exist over the executive order, which is scant on details.

Medicare should not pay more for products in Parts B and D than the most- favored-nation price, says the order. That price is defined as the lowest one for a product that its manufacturer sells “in a member country of the Organisation for Economic Co-operation and Development (OECD) that has a comparable per-capita gross domestic product.” The proposal calls for the HHS secretary — currently Alex Azar — “to implement his rulemaking plan” in Part B and “develop and implement a rulemaking plan” in Part D to test payment models in which Medicare would not pay more than the most-favored-nation price to determine whether they “would mitigate poor clinical outcomes and increased expenditures associated with high drug costs.” The order also revoked a July 24 executive order that applied the most-favored-nation proposal to Part B only.

✦ Rep. Carolyn Maloney (D-N.Y.) said she plans to issue a subpoena to AbbVie Inc. for documents relating to Humira (adalimumab) and Imbruvica (ibrutinib). Maloney is the chairwoman of the Committee on Oversight and Reform and is seeking information on drug pricing as part of an investigation started by the committee’s former chairman, Rep. Elijah Cummings (D-Md.), in January 2019 of 12 drug companies selling 19 of the costliest medications. Maloney, who unveiled her intentions via a Sept. 1 memo, said in that document that during the investigation, “AbbVie repeatedly failed to comply with the Committee’s requests and provided inadequate responses regarding Humira and Imbruvica. AbbVie has produced only limited documents about its pricing practices and strategies to preserve market share and pricing power for both products.” The Hill reports that an AbbVie spokesperson said the company has “provided thousands of documents and [has] had numerous conversations with the Committee staff. While we are surprised and disappointed the Committee chose to take this action, we will continue to work in good faith with them on this important subject.” View the memo at https://bit.ly/2EZEytx.

✦ Mylan N.V. launched the first FDA-approved generic of Biogen’s multiple sclerosis drug Tecfidera (dimethyl fumarate) on Aug. 19. The move came two months after the U.S. District Court for the Northern District of West Virginia ruled in favor of Mylan (RSP 7/20, p. 12), invalidating a Tecfidera patent that wasn’t set to expire until 2028 (No. 1:17-cv-00116-IMK-JPM). Mylan’s drug at the time had an action date of Nov. 16, but the drugmaker worked with the FDA to move that up in the wake of the decision. Mylan did not respond to AIS Health requests for information on the drug’s price, but Evercore ISI analyst Umer Raffat said it was approximately a 14% discount to Tecfidera. According to the National MS Society, Tecfidera’s wholesale acquisition cost was $94,991 as of Nov. 13, 2019. A Jan. 3 Boston Business Journal article says Biogen raised the price 6% this year, putting its annual cost at $100,690. Visit https://bit.ly/2R6JS0H.

✦ Aug. 5: The FDA gave accelerated approval to GlaxoSmithKline’s Blenrep (belantamab mafodotin-blmf) for adults with relapsed or refractory multiple myeloma who have received at least four prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor and an immunotherapy agent. The agency granted the first-in-class anti-B-cell maturation antigen (anti-BCMA)-directed antibody priority review, as well as orphan drug and breakthrough therapy designations. The review was via the Real-Time Oncology Review. Recommended dosing is 2.5 mg/kg as an intravenous infusion over approximately 30 minutes once every three weeks. The price per 100 mg single-dose vial is $8,277; based on a patient weight of 175 pounds, the monthly treatment cost would be $23,900. Visit www.blenrep.com.

✦ Aug. 7: The FDA approved Guardant Health, Inc.’s Guardant360 CDx for tumor mutation profiling in people with any solid malignant neoplasm. The agency also approved the test as a companion diagnostic to identify people with non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) alterations who may benefit from treatment with AstraZeneca’s Tagrisso (osimertinib). Visit https://guardant360.com.

One common characteristic of specialty medications is that they require special handling. Quite often that means they need to remain refrigerated or frozen, which is critical while drugs are being transported to patients and providers. To help ensure these products’ integrity — and, in turn, improve patient outcomes and reduce pharmaceutical waste — AllianceRx Walgreens Prime has begun using a new patented process when shipping specialty products.

When a drug needs to remain at a cool temperature and it isn’t, that results in drug waste and reshipment. But that assumes that the person receiving the drug knows it’s been compromised. If that’s not the case, and the product has lost its potency, that puts people’s health at risk if they are taking an ineffective drug. It also means that a payer is reimbursing for an inadequate drug.

The spinal muscular atrophy (SMA) therapeutic category continues to expand with the Aug. 7 FDA approval of Evrysdi (risdiplam) from Roche Group member Genentech, Inc. Industry experts maintain that the drug has the potential to significantly impact the class for a variety of reasons, including its route of administration and price.

People with SMA cannot produce enough SMN protein, leading to the loss of motor neurons, which results in problems breathing, swallowing, speaking and walking. Before a therapy was available to treat SMA, the condition was the No. 1 genetic cause of infant death.