Proposed Method of Reimbursement for Biosimilars

The Biosimilars Forum issued comments in response to the 2016 proposed rules released by the Center for Medicare and Medicaid Services (CMS) regarding biosimilar payment. As currently written, the Part B rule proposes that multiple biosimilars to the same reference product be grouped and issued the same J-code for Medicare reimbursement purposes.

The following is a summary of the Biosimilars Forum’s general comments to the proposed Part B rule. 

Biosimilars Forum’s General Comments to the Proposed Rule 

We strongly disagree with CMS’s intent to group all biosimilar products of a single reference product under the same HCPCS code. We urge CMS to enact a final payment rule that assigns each biosimilar product of a reference biologic its own payment amount and a unique HCPCS code. CMS’s proposed approach contradicts the statutory language of the Section 1847A of the Social Security Act. In addition, CMS’s interpretation inappropriately treats biosimilar products as if they were multisource or generic drugs. This treatment is inconsistent with not only how the Food and Drug Administration (“FDA”) classifies biosimilars, but also how CMS itself defines biosimilar products under Medicaid and Medicare Part D. Finally, CMS’s proposed payment methodology is likely to dramatically reduce investment in, and the subsequent availability of, biosimilar products, which is clearly against the intent of Congress in providing for a vibrant U.S. biosimilars market."

To read the Forum’s complete comments, click here: (Part B Submission (PDF File) and HOPPS NPRM Submission (PDF File)).

FDA Issues Label Change for ADCETRIS®

On Aug 17, 2015, the FDA issued a label change for ADCETRIS® (brentuximab vedotin). 

 Key label changes include:

FDA approval for the treatment of patients with Classical Hodgkin Lymphoma Patients at High Risk of Relapse or Progression as Post-Autologous Hematopoietic Stem Cell Transplantation Consolidation. This approval was based upon data from the placebo-controlled randomized AETHERA trial.

Click Here for the updated USPI.

FDA Approves New Indication for Kyprolis

Onyx Pharmaceuticals Inc., an Amgen subsidiary, announced that on July 24, 2015, the U.S. Food and Drug Administration approved a new indication for Kyprolis® (carfilzomib) for injection. KYPROLIS can now be used in combination with lenalidomide and dexamethasone for the treatment of patients with relapsed multiple myeloma who have received one to three prior lines of therapy.

Trade Name - KYPROLIS

 

Strength - 60MG

 

NDC* - 76075-0101-01

 

Pack Size - 60mg X 1 Vial

Dosage Form - Injection, Powder, Lyophilized, for Solution

*Note that the product's NDC code has been "zero-filled" to ensure creation of an 11-digit code that meets CMS standards. The zero-fill location is indicated in bold.2

If you require any additional information or have specific questions regarding this correspondence, please contact the Onyx Pharmaceuticals 360™ Program at 855-ONYX-360 (855-669-9360).

 

 Click Here to read the Prescribing Information.

Celgene Implements Commercial Co-pay program for ISTODAX®

Celgene has recently implemented a Celgene Commercial Co-pay Program for eligible patients taking ISTODAX® (romidepsin) for injection. To qualify for the program, a patient must: (i) have an annual household income of less than $100,000, (ii) maintain commercial or private health insurance, and (iii) reside in the United States or Puerto Rico. Certain qualifying patients may be eligible to reduce their out-of-pocket co-pay responsibility for ISTODAX to $0. Also, co-pay assistance may be available for patients who have Medicare, Medicaid, or other government- sponsored insurance through unaffiliated, independent, third-party organizations such as the Patient Access Network Foundation.

 

Your patients can find out more about these programs and others by calling Celgene Patient Support® at 1-800-931-8691, Monday – Friday, 8 AM – 7 PM ET.

Updated Labeling for Celgene's POMALYST®

Celgene recently announced an updated labeling for POMALYST® for use in  multiple myeloma. Please Click Here for an announcement of these important updates.

Top 5 Claims Mistakes Video

Click Here to view a Short Video on How to Avoid Common Documentation Errors

News Update for Oncotype DX®

On May 11, 2015 Genomic Health announced the following:

St. Gallen International Breast Cancer Guidelines Selects Oncotype DX® as the Only Multi-Gene Test Validated to Predict Chemotherapy Benefit

Congress Passes Bill to Repeal SGR

Late last night, the Senate passed H.R. 2, the “Medicare Access and Chip Reauthorization Act,” (MACRA), by a vote of 92-8. This bill is the same bill that was passed by the House on March 26 by a vote of 392-37.The bill now goes to President Obama for his signature. 

Among the bill’s significant provisions:

  • Replaces the SGR with an increase of 0.5% in Medicare physician reimbursement starting in July 2015 through December 2015, and then annual 0.5% increases lasting through 2019.
  • Consolidates reporting programs, such as the Meaningful Use program for electronic health records and several quality reporting programs, into a new, merit-based incentive payment system.
  • Incentivizes physicians to participate in alternative payment models such as accountable care organizations (ACOs).
  • Extends the floor on the Work GPCI.
  • Implements income-related premium adjustments for Parts B and D for higher-income Medicare beneficiaries. 

We will post additional information on this historic bill once we have had time to thoroughly review it. 

CLICK HERE to Read the bill as passed by Congress.