The physician's role in market access
In the past, new pharmaceutical agents seemed to arrive and become available to physicians without any effort on their parts. Drugs that were covered by insurance plans often required little or no input from the prescriber to obtain them and most drugs would end up on provincial formularies in one form or another after a period of time.
With the advent of much more expensive, extremely useful classes of drugs such as the biologic agents for inflammatory arthritis, market access has become a major issue for patients, physicians and payers. At the same time, these drugs have revolutionized the care of patients with inflammatory rheumatic diseases throughout the world.
"With the advent of much more expensive, extremely useful classes of drugs such as the biologic agents for inflammatory arthritis, market access has become a major issue for patients, physicians and payers."
Rheumatoid arthritis affects 1% of the general population and in the past was a disease with significant disability and deformity. Now, with the advent of effective new therapies, damage and deformity can be avoided and many patients can enjoy significant symptom relief, prevention of joint damage and the chance for a normal life. It is estimated that up to 20% of RA patients in Ontario will be on a biologic and though this is not a large number of patients, it represents a significant cost.
There are new treatment paradigms for the therapy of rheumatic diseases and guidelines, such as those created by the Canadian Rheumatology Association have become accepted as the standard of care and include important concepts such as treating to target as well as the appropriate use of biologic drugs within the available pharmacologic therapies. These continue to espouse the use of traditional small molecules such as methotrexate as the initial therapy, and suggest moving to biologics only when this treatment has been tried for sufficient time without reaching an acceptable low disease activity state.
Moving forward with market access
The government payers began to utilize programs to address patient access to biologics with forms and criteria such as the Exceptional Access Program (EAP).
With this success the Ontario Rheumatology Association (ORA) has helped to facilitate the following:-
- Payers have been engaging in ongoing discussions on the subjects of convergence of activities such as development of approval criteria, first and second line therapy, renewal intervals and renewal criteria.
- This has led to the creation of forms for access to biologics for patients with rheumatic diseases designed with and accepted by the Province of Ontario's Exceptional Access Program for government funded patients.
- With this significant success, the provincial government has improved drug access for patients by refining criteria as new drugs or new indications emerge.
- Specialist groups' meetings with the government to derive criteria that are acceptable to both government and prescribers have also been facilitated.
"It is estimated that up to 20% of RA patients in Ontario will be on a biologic and though this is not a large number of patients, it represents a significant cost."
- Numerous third party payers are now putting in place new prior authorization forms and criteria for the prescribing of biologic drugs.
- Several large insurance companies have been creating forms and selecting patient criteria to allow rational access to drugs, as well as looking for ways it can work on important projects such as the Ontario Best Practices Research Initiative (OBRI). It is hoped that this initiative will allow the appropriate access to medication for patients with rheumatic diseases (the right drug at the right time for the right patient).
The future
Pharmaceutical companies need to continue to have regular dialogue on subjects around barriers to patient access to medication to enhance and streamline this process for all Ontarians.
All levels of government, as well as private payers need to work in an ongoing proactive way to harmonize drug access criteria and forms to bring all patient access into alignment with recognized and accepted guidelines for rheumatic diseases.
In addition, data needs to be collected on these interactions to ensure best possible patient outcomes using all the appropriate treatments available to us. Working with all involved stakeholders, the Ontario Rheumatology Association is also looking at new Models of Care in the treatment of inflammatory arthritis, to utilize all the resources available to their maximum .
With this ongoing effort, we can make the best possible use of the resources available to all our patients now and as we move forwards.
About the author:
Dr. Jane Purvis is a community rheumatologist working in Peterborough, Ontario and is the current president of the Ontario Rheumatology Association. The mission of the Ontario Rheumatology Association is to represent Ontario Rheumatologists and promote their pursuit of excellence in Arthritis care in Ontario through leadership, advocacy, education and communications. The ORA has numerous projects including Models of Care, Electronic Medical Records for rheumatologists, manpower planning as well as maintaining ongoing dialogue with the provincial government and third party payers. Dr. Purvis can be reached at president@ontariorheum.ca and the ORA website is http://www.ontariorheum.ca.
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