Oncology

New FDA Approvals: The FDA Approved Amneal’s Alymsys

April 13: The FDA approved Amneal Pharmaceuticals, Inc.’s Alymsys (bevacizumab-maly) for the treatment of multiple conditions: (1) first- or second-line treatment of metastatic colorectal cancer in combination with intravenous fluorouracil-based chemotherapy; (2) second-line treatment of metastatic colorectal cancer in combination with fluoropyrimidine-irinotecan or fluoropyrimidine-oxaliplatin chemotherapy in people who have progressed on a first-line bevacizumab product; (3) first-line treatment of unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer in combination with carboplatin and paclitaxel; (4) recurrent glioblastoma in adults; (5) metastatic renal cell carcinoma in combination with interferon alfa; (6) persistent, recurrent or metastatic cervical cancer in combination with paclitaxel and cisplatin or paclitaxel and topotecan; and (7) epithelial ovarian, fallopian tube or primary peritoneal cancer in combination with paclitaxel, pegylated liposomal doxorubicin or topotecan for platinum-resistant recurrent disease in people receiving no more than two prior chemotherapy regimens. The vascular endothelial growth factor inhibitor is the third biosimilar of Roche Group member Genentech USA, Inc.’s Avastin (bevacizumab) that the agency has approved. Dosing of the intravenous infusion is based on indication.

A Look at Third-Party Oncology Clinical Pathways

In order to improve patient outcomes and reduce variations in oncology care, more and more payers and providers are adopting oncology clinical pathways (OCPs) — treatment protocols that aim to provide the optimal cancer care to patients at the lowest cost, according to a recent MMIT webinar. The share of oncologists exposed to third-party oncology pathways increased from 20% in 2015 to 52% in 2021, with one third of oncologists choosing a provider-focused pathway as of the fourth quarter of 2021. Breast cancer, multiple myeloma and non-small cell lung cancer are among the top therapeutic areas managed by third-party pathways.

CMS Rule on Pharma Patient-Assistance Programs Could Cut Back on Aid

CMS’s stance has long been that manufacturer-provided assistance given to patients is excluded from best price and average manufacturer price (AMP) calculation for prescription drugs. However, the rise of copayment accumulators and maximizers — and health insurers’ subsequent taking of this assistance rather than allowing it to count toward patients’ deductibles and out-of-pocket maximums — have caused the agency to rethink its position. A rule slated to take effect at the beginning of 2023 would reverse that longtime approach, potentially resulting in increased patient out-of-pocket costs for drugs and pharma companies being on the hook for ensuring they know exactly where their assistance is going, industry experts tell AIS Health, a division of MMIT.

The Medicaid rebate rule allows state Medicaid programs to get the same discounts on drug prices that manufacturers offer commercial plans purchasing prescription drugs. Manufacturers pay rebates to Medicaid programs that are calculated based on drugmakers’ best price, which is the lowest price the manufacturer gives to most providers of health care services or items, including hospitals, HMOs and MCOs — but not patients. It includes any price adjustments, such as discounts and rebates, but not manufacturer-provided assistance to patients.

A Look at Third-Party Oncology Clinical Pathways

In order to improve patient outcomes and reduce variations in oncology care, more and more payers and providers are adopting oncology clinical pathways (OCPs) — treatment protocols that aim to provide the optimal cancer care to patients at the lowest cost, according to a recent MMIT webinar. The share of oncologists exposed to third-party oncology pathways increased from 20% in 2015 to 52% in 2021, with one third of oncologists choosing a provider-focused pathway as of the fourth quarter of 2021. Breast cancer, multiple myeloma and non-small cell lung cancer are among the top therapeutic areas managed by third-party pathways.

A Look at Third-Party Oncology Clinical Pathways

In order to improve patient outcomes and reduce variations in oncology care, more and more payers and providers are adopting oncology clinical pathways (OCPs) — treatment protocols that aim to provide the optimal cancer care to patients at the lowest cost, according to a recent MMIT webinar. The share of oncologists exposed to third-party oncology pathways increased from 20% in 2015 to 52% in 2021, with one third of oncologists choosing a provider-focused pathway as of the fourth quarter of 2021. Breast cancer, multiple myeloma and non-small cell lung cancer are among the top therapeutic areas managed by third-party pathways.

Novartis’ Pluvicto Brings New Option to mCRPC Treatment

A new prostate cancer drug is sparking interest among payers and oncologists alike, according to a survey by Zitter Insights.

On March 23, the FDA approved Novartis Pharmaceuticals Corp.’s Pluvicto (lutetium Lu 177 vipivotide tetraxetan) (formerly referred to as 177Lu-PSMA-617) for the treatment of prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) in people who have been treated with androgen receptor pathway inhibition and taxane-based chemotherapy. The product from Novartis unit Advanced Accelerator Applications USA, Inc. is the first FDA-approved targeted radioligand therapy for eligible people with mCRPC that combines a targeting compound with a therapeutic radioisotope.

CMS Targets Patient-Assistance Programs; Rule Could Curtail Aid

CMS’s stance has long been that manufacturer-provided assistance given to patients is excluded from Best Price and average manufacturer price (AMP) calculation for prescription drugs. However, the rise of copayment accumulators and maximizers and health insurers’ subsequent taking of this assistance rather than allowing it to count toward patients’ deductibles and out-of-pocket maximums have caused the agency to rethink its position. A rule slated to take effect at the beginning of 2023 would reverse that longtime approach, potentially resulting in increased patient out-of-pocket costs for drugs and pharma companies being on the hook for ensuring they know exactly where their assistance is going, industry experts tell AIS Health, a division of MMIT.

The Medicaid rebate rule allows state Medicaid programs to get the same discounts on drug prices that manufacturers offer commercial plans purchasing prescription drugs. Manufacturers pay rebates to Medicaid programs that are calculated based on drugmakers’ Best Price, which is the lowest price the manufacturer gives to most providers of health care services or items, including hospitals, HMOs and MCOs — but not patients. It includes any price adjustments, such as discounts and rebates, but not manufacturer-provided assistance to patients.

Carvykti Approval Brings Second CAR-T to Multiple Myeloma Treatment

With its Feb. 28 approval, the Janssen Pharmaceutical Companies of Johnson & Johnson and Legend Biotech USA, Inc.’s Carvykti (ciltacabtagene autoleucel; cilta-cel) becomes the second chimeric antigen receptor T-cell (CAR-T) therapy to treat multiple myeloma. Payers report being less likely to prefer it over some or all other multiple myeloma treatments with a similar indication, but oncologists are showing more enthusiasm for prescribing the new agent, according to Zitter Insights.

The FDA approved Carvykti for the treatment of adults with relapsed or refractory multiple myeloma after at least four lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody. The product is a B-cell maturation antigen (BCMA)-directed CAR-T agent. The one-time treatment will have a phased launch and will be available through a limited network of certified treatment centers. The FDA gave the drug breakthrough therapy and orphan drug designations. The therapy’s wholesale acquisition cost is $465,000.

New FDA Approvals: The FDA Granted an Additional Indication to Lynparza

March 11: The FDA granted an additional indication to AstraZeneca and Merck & Co., Inc.’s Lynparza (olaparib) for the treatment of people with germline BRCA-mutated human epidermal growth factor receptor 2 (HER2)-negative high-risk early breast cancer who have been treated with chemotherapy before or after surgery. The agency first approved the tablet on Dec. 19, 2014. Dosing is 300 mg twice daily. Website Drugs.com lists the price of 60 150 mg tablets as more than $7,778.

March 11: The FDA approved another use for Myriad Genetics, Inc.’s BRACAnalysis CDx test as a companion diagnostic to identify people with germline BRCA-mutated HER2-negative, high-risk early-stage breast cancer who may benefit from Lynparza (see above brief). The test detects and interprets germline BRCA1 and BRCA2 variants. The agency initially approved the test on Dec. 19, 2014.

Oncologists Are Showing More Enthusiasm for Carvykti Than Are Payers

With its Feb. 28 approval, the Janssen Pharmaceutical Companies of Johnson & Johnson and Legend Biotech USA, Inc.’s Carvykti (ciltacabtagene autoleucel; cilta-cel) becomes the second chimeric antigen receptor T-cell (CAR-T) therapy to treat multiple myeloma. Payers report being less likely to prefer it over some or all other multiple myeloma treatments with a similar indication, but oncologists are showing more enthusiasm for prescribing the new agent, according to Zitter Insights.

The FDA approved Carvykti for the treatment of adults with relapsed or refractory multiple myeloma after at least four lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody. The product is a B-cell maturation antigen (BCMA)-directed CAR-T agent. The one-time treatment will have a phased launch and will be available through a limited network of certified treatment centers. The FDA gave the drug breakthrough therapy and orphan drug designations. The therapy’s wholesale acquisition cost is $465,000.