Radar on Specialty Pharmacy

✦ July 30: The FDA granted premarket approval to Pillar Biosciences, Inc.’s ONCO/Reveal Dx Lung and Colon Cancer Assay as a companion diagnostic for all FDA-approved epidermal growth factor receptor tyrosine kinase inhibitor (TKI) therapies for non-small cell lung cancer (NSCLC) targeting EGFR and KRAS wild-type tumor tissue for metastatic colorectal cancer patients. The in vitro diagnostic kit is intended to be used on the Illumina MiSeq Dx instrument.

✦ Aug. 2: The FDA approved Astra-Zeneca’s Saphnelo (anifrolumab-fnia) to treat adults with moderate to severe systemic lupus erythematosus who are receiving standard therapy. It is the first type I interferon (type I IFN) receptor antagonist to gain FDA approval and the first product approved for the most common form of lupus in more than 10 years. The recommended dose is 300 mg via a 30-minute intravenous infusion every four weeks. Drugs.com lists the price of one 100 mg vial as more than $1,799.00.

The FDA recently expanded the indication of a drug for certain types of urothelial cancer, the most common form of bladder cancer. Payers and oncologists appear to be divided, however, on the drug’s place in a treatment regimen. But in a therapeutic class with limited therapeutic options, the approvals are a welcome addition, particularly in the second-line setting.

On July 9, the FDA gave an additional approval to Astellas Pharma US, Inc. and Seagen Inc.’s Padcev (enfortumab vedotin-ejfv) for the treatment of adults with locally advanced or metastatic urothelial cancer who are ineligible for cisplatin-containing chemotherapy and have received at least one line of therapy. The agency also converted the Nectin-4-directed antibody and microtubule inhibitor conjugate’s accelerated approval, granted Dec. 18, 2019, to regular approval for the treatment of adults with locally advanced or metastatic urothelial cancer who have received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and a platinum-containing chemotherapy before or after surgery or in a locally advanced or metastatic urothelial cancer setting.

The seventh indication since late December for an immunotherapy is being withdrawn from the U.S. market. All of the indications were granted through accelerated approval. All of the affected therapies have other FDA-approved indications.

On Aug. 27, Genentech USA, Inc., a member of the Roche Group, said it will voluntarily withdraw the accelerated approval for Tecentriq (atezolizumab) in combination with chemotherapy (Abraxane, albumin-bound paclitaxel; nab-paclitaxel) for the treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumors express programmed death-ligand 1 (PD-L1), as determined by an FDA-approved test. It does not impact other approved indications for Tecentriq in the U.S. or TNBC approvals outside the U.S. The FDA gave the drug accelerated approval for TNBC on March 8, 2019.

Bipartisan groups in both the Senate and the House have introduced bills aimed at changing the way the professional services benefit for Medicare Part B home infusion therapies is implemented. The current situation, industry experts maintain, has resulted in providers directing these beneficiaries to another setting such as the hospital outpatient department or a skilled nursing facility, which is particularly concerning during the COVID-19 pandemic.

On Aug. 5, Sens. Mark Warner (D-Va.) and Tim Scott (R-S.C.) introduced S.2652, the Preserving Patient Access to Home Infusion Act. A couple weeks later on Aug. 20, Reps. Terri Sewell (D-Ala.), Debbie Dingell (D-Mich.), Fred Upton (R-Mich.) and Vern Buchannan (R-Fla.) introduced a companion bill, H.R.5067. The Senate bill was referred to the Committee on Finance, while the House bill was referred to the Energy and Commerce and Ways and Means committees.

As payers continue to search for ways to reduce their drug spend, one health plan recently rolled out a dose reduction program for some oncology therapies. Anthem Blue Cross and Blue Shield is asking providers in certain situations to “voluntarily reduce the requested dose to the nearest whole vial,” according to provider newsletters. The policy went into effect July 1.

A review of the policy in Anthem provider bulletins across various states revealed that some, such as California, are restricted to Medicare Advantage plan members, but others, such as Missouri, simply refer to “members covered by Anthem Blue Cross and Blue Shield.”