Manufacturers of biologic drugs over the past few years have been “pulling out all the stops” to difficult for less expensive biosimilar products to come to market. Biologic drug manufactures have used tactics like patent infringement suits to delay the availability of biosimilars.
Note: Biosimilars are the “generic” equivalent of a biologic drug. Unlike traditional drugs, biologics are made from living cells and cannot be copied exactly to make generic versions. They are used to treat a range of conditions, including Crohn’s disease, ulcerative colitis, rheumatoid arthritis, plaque psoriasis, breast cancer and diabetes.
The U.S. Supreme Court, in a recent 9-0 ruling, reduced one of the barriers for biosimilars by overturning a lower court’s decision that had prevented biosilimar drugs from coming to market quickly.
As an example swiss pharmaceutical company Novartis has been prevented from marketing a biosimilar of California-based Amgen’s Neupogen until six months after the U.S. Food and Drug Administration (FDA) approved it.
Payers are expecting biosimilars to be cheaper than the original biologic. As biologics are comparatively very expensive drugs and are accounting for an ever-increasing share of prescription drug costs payers are expecting significant cost savings from biosimilars. The delay in getting biosimilars to market is costing payers and, in turn, patients and employers billions of dollars each year.
Cost Saving Example
Novartis’ Sandoz unit began selling Zarxio in September of 2015. Zarixio is the first biosimilar drug to win FDA approval. Zarxio is a biosimilar of Amgen’s Neupogen. Both boost white blood cell counts in cancer patients to help fight infections. Zarxio came to market at a 15 percent cost reduction over Neupogen. Sales of Neupogen, meanwhile, dropped from more than $1 billion in 2015 to $765 million last year, primarily due to competition in the United States, the company said in regulatory filings.
With the recent Supreme court decision less expensive biosimilars are expected to come to market at a faster rate and provide a cost saving opportunity for both payers and patients.
Preparing for Biosimilars
As biosimilars are not exact copies of biologics, taking advantage of their cost saving potential will require more preparation. In addition, converting patients from biologics to biosimilars may require a more “hands on” process than a step or formulary edit might provide.
- Payers should be confirming that their delegated P&T (pharmacy and therapeutics) committee has conducted a clinical review to determine how best to cover and position the biosimilar.
- Payers should confirm that the adopted coverage criteria are being administered by their PBMs and TPAs.
- Payers may also want to review their contracts to understand how biosimilar rebates are accounted for. Unlike oral generics, many biosimilars and follow-on biologics can generate significant rebates. Yet many contracts are silent on how these dollars should be handled, and may actually exclude biosimilars from the rebate pass-through commitment.
- Payers may want to consider an active conversion process for patients currently using more expensive biologics. Programs (such as medication management – see below) should be considered to educate physicians and members, encourage the acceptance and adoption of biosimilars as viable, cost-effective treatment options, and monitor the initial course of biosimilar therapy.
Biosimilar and “Market Similar”
While biosimilars are less expensive than comparable biologics, they will still tend to be relatively expensive. Consequently, P&T review of a biosimilar should also assure the biosimilar is also “market similar” That is, does the biosimilar provide comparable:
- Financial-assistance programs.
- Educational support
- Distribution channels
Where to start?
A good place to begin evaluating biologics and biosimilars is with the anti-inflammatory class. In terms of spend, anti-inflamatories constitute about 50% of all biologic spend. They are used in a wide variety of conditions including lupus, celiac disease, psoriasis, inflammatory bowel disease and rheumatoid arthritis. Anti-inflammatory biologic drugs and their biosimilar comparators are represented in the table below.
Biosimilars and Medication Management Programs
Conversion from a biologic to its comparator biosimilar will require a “gentler hand” than might be provided by a simple PBM edit. Prescribers will require education as will patients. Additionally, patients will require navigation (e.g. accessing financial assistance, etc.) and monitoring services. Medication management programs are uniquely suited to facilitate this type of drug therapy conversion. Optimally, a biosimilar focused medication management program would have a prescriber component designed to educate prescribers regarding alternatives, benefits and conversion parameters and a patient focused component which would provide patient education and obtain patient approval and once the patient has agreed, assure that new prescriptions, financial assistance, drug delivery and patient education are coordinated on behalf of the patient.