Multiple myeloma is a condition wherein plasma cells, which are a type of white blood cells in the bone marrow, become cancerous and start multiplying. This condition can damage the bones, immune system, and kidneys and the treatment for myeloma depends on the stage of cancer. Options include medication, corticosteroids, chemotherapy, and radiation; a stem-cell transplant may also be done.
Cost of treatment
There have been major advances in the last 15 years in the diagnosis and treatment of multiple myeloma. Overall, survival has remarkably improved during this period due to the research and introduction of new medications. But the costs of treating myeloma are very high, more than other oncology treatments. The cost is amplified in three ways: first, treatment requires a combination of multiple medications; second, treatment is usually done in the form of continuous or maintenance therapy, due to which costs are not temporary but continual; third, as survival through multiple myeloma has remarkably improved, the cumulative cost of care over the lifetime of a patient is very high.
The costs for treatment for multiple myeloma can include approximately $150,000 per annum for medication and treatment, and around $100,000 per annum for maintenance and care after initial treatment. These costs not only affect the patient but also society as a whole. Introducing biosimilars to replace biologics – many of whose patents are due to expire – can result in huge savings, projected to be to the tune of $54 billion from 2017 to 2026.
Comparing biologics and biosimilars
Biologic medicines are transforming cancer treatment by targeting the key path that underlies the mechanism of the disease. They are more active and less toxic in the treatment of cancer than the previous generations of small-molecule medications. The research, manufacturing, and introduction cost of biologics is high, which explains why cancer medication is very expensive. Biosimilars, which are a copy of biologics, are more expensive than generics. Since biologics are complex molecules produced by living cells, developing identical biosimilars is very difficult and in many cases impossible. Monoclonal antibodies are the replacements of the complex molecules and they have an increased structural complexity hence evaluation costs are high.
Biosimilar medications to treat multiple myeloma
Can biosimilars replace biologics? Although biosimilars offer new hope in oncological treatment, many questions are raised regarding the use of biosimilars in the country. Medical practitioners are hesitant in accepting and recommending biosimilars in the treatment of multiple myeloma. Physicians are still evaluating the implications of accepting biosimilars in the future. The regulatory practices for approval of biosimilars are mostly dependant on only clinical studies rather than phase III trials, which limit the medical practitioner’s confidence in recommending these therapies. The naming of these biosimilars is still not clear and it is confusing. Clarity about payment by insurers for use of biosimilars should be given. Any small difference in manufacturing can lead to discrepancies in immunogenicity and have adverse effects over time.
To overcome these challenges, robust education and training on biosimilars should be offered to doctors, nurses, pharmacists, and patients. Educational material should be given to disseminating information on the use of biosimilars in oncology treatment. While they are confident with biologics they may not be as confident about biosimilars. In 2018, the American Society of Clinical Oncology released a statement that expands on the safety, efficacy, and integration of biosimilars into practice and on naming, labeling, and the regulation of practices. This guidance is a step in the right direction in bridging the knowledge gap.
Biosimilars such as Filgrastim and Epoetin have been used in Europe since 2008 to treat multiple myeloma. Various studies have been conducted to show that patient access and response to treatment can be significantly improved with biosimilars.
The FDA’s role
The FDA steps in to ensure safety during the clinical trials and introduction and usage phase of the biosimilars. Those manufacturing biosimilar medications have to work closely with regulatory authorities and submit necessary reports to obtain approvals. If the FDA suspects any risks or adverse effects on being treated with biosimilars it immediately halts recruiting new trial enrolments or prescriptions depending on the stage of the trial. The FDA’s real-time oncology review process closely and swiftly monitors any new trials and introductions so that safe and cost-effective biosimilars are made available to patients as soon as possible.
Healthcare providers should be educated about and understand the FDA’s 351 (k) approval pathway for biosimilars. This will create a clearer picture of the rigorous testing of these products experience. Lack of this knowledge is a setback as the doctors are hesitant in prescribing biosimilars, doubting their safety and potential benefits.
The first biosimilars approved by FDA for treatment of multiple myeloma is Filgrastim. Filgrastim is used to increase the white blood cell count in patients before a stem cell transplant. Thalomid, Revlimid, and Velcade are other biosimilars used in the treatment of multiple myeloma.
This year, the FDA has finalized the long-awaited guidance on how biosimilars can achieve an interchangeable status. This means they may be substituted for the reference biologic without a prescriber intervening. Noninterchangeable biosimilars have been approved earlier on, which is nothing short of a breakthrough.