Radar on Specialty Pharmacy

The seventh indication since late December for an immunotherapy is being withdrawn from the U.S. market.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.”

✦ Bristol Myers Squibb will voluntarily withdraw the U.S. indication for Opdivo (nivolumab) as a monotherapy for people with hepatocellular carcinoma who previously were treated with sorafenib. The move follows an April meeting of the agency’s Oncologic Drugs Advisory Committee to discuss whether to keep certain indications for a handful of checkpoint inhibitors that target programmed death-1/programmed death-ligand 1 (PD-1/PD-L1) and received accelerated approval but had not met post-marketing requirements demonstrating confirmatory benefit. Opdivo received a negative vote for this indication, as did Merck & Co., Inc.’s Keytruda (pembrolizumab) for the treatment of people with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 with disease progression on or after at least two lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and, if appropriate, human epidermal growth factor receptor 2/neu-targeted therapy. Merck said recently that it would voluntarily withdraw that indication in the U.S.

✦ Bristol Myers Squibb also will withdraw the indication for Istodax (romidepsin) as monotherapy for the treatment of peripheral T-cell lymphoma in adults who have received at least one prior therapy. The FDA initially gave the drug from Celgene Corp., now a Bristol Myers Squibb subsidiary, accelerated approval. A confirmatory Phase III trial did not meet the primary efficacy endpoint of progression free survival.

✦ 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. Dosing for both indications is 1.25 mg/kg via a 30-minute intravenous infusion on days one, eight and 15 of a 28-day cycle. Website Drugs.com lists the price of a 20 mg lyophilized powder as more than $2,380.00.

✦ July 12: The FDA granted another indication to the Janssen Pharmaceutical Companies of Johnson & Johnson’s Darzalex Faspro (daratumumab and hyaluronidase-fihj) in combination with pomalidomide and dexamethasone for the treatment of adults with multiple myeloma who have received at least one line of therapy, including lenalidomide and a proteasome inhibitor. The agency initially approved the anti-CD38 monoclonal antibody on May 1, 2020. The recommended dosage is 1,800 mg/30,000 units subcutaneously into the abdomen over approximately three to five minutes weekly for weeks one to eight, every two weeks from weeks nine to 24 and then every four weeks. Drugs.com lists the price of an 1,800 mg/30,000 per 15 mL vial as more than $8,290.