Patient health and safety advocates and the biopharmaceutical industry share a commitment to improve patient care and safety to removing obstacles to physician-prescribed medications. At the recent BIO Patient and Health Advocacy Summit, advocates and industry met to discuss these shared concerns. Representatives from the Physician-Patient Alliance for Health & Safety attended the Summit.
There were two major key concerns discussed:
- The Cost of Medications and, more particularly, the total costs to the patient of such medications. These costs concerns were not related to the list price for the medication (despite an announcement on the first day of the Summit from the current administration), but to the actual out of pocket expenses that the patient must incur when following physician-prescribed regimens – e.g., co-pays and health insurance deductibles.
- Impediments to the Sanctity of the Physician-Patient Relationship and the ability of physicians to prescribe medications that they believe are in the best interests of their patient’s health and care.
Matters that restrict the sanctity of the physician-patient relationship include:
- Step Therapies, which interfere with patient access and the physician-patient relationship by requiring that patients must first try a less expensive drug on formulary and fail on it before being allowed to move up or “step up” to the more expensive drug that was initially prescribed by their physicians. Step therapies “prevent and delay important treatments for patients” (according to the American College of Rheumatology). Alarmingly, the use of step therapies to limit prescription fulfillment is increasing. Although the use of step therapies were previously discouraged by CMS, starting in 2019, CMS will be allowing Medicare advantage plans to use step therapy for drugs under Part B, as part of an effort to combat rising drug prices. Although CMS’ Guidance does not mention cardiovascular drugs, there is no guarantee that CV medications may not be subject to Medicare step therapies.
- Prior Authorizations (“PAs”), which impede patient access to physician-prescribed drugs by requiring the prescribing physician to get approval from the patient’s insurance company before the prescription can be filled for the patient. PAs affect the timing of the delivery of physician-recommended treatment and are an obstacle to patient adherence, all of which impact the optimum continuum of care:
- PAs make it easier to prescribe another drug – almost 90% of physicians reported that the administrative burden related to PA requests has risen in the last five years, with most saying it has “increased significantly.” By increasing the administrative burden on physicians, physicians may be reluctant to prescribe a certain medication even if it would their first choice for treatment just because of the administrative burden of doing so. “While most of these PA requests ultimately get approved, the time my staff and I spend filling out lengthy forms and calling health plans to appeal is substantial—and those are hours I am unable to spend face to face with patients,” said Jack Resneck Jr., MD, a health policy expert and professor of dermatology at the University of California, San Francisco. “My practice has several medical assistants who spend countless hours helping our physicians on PAs each week.”
- PAs delay the filling and taking of prescriptions – PA issues contribute to 92% of care delays. Delaying of filling of prescriptions not only cause delays in treatment, but can contribute to patient non-adherence to physician-recommended treatment. 92% of physicians believe PAs harm patient access to care.
- Quantity Limitations, which delay treatment and can cause patient non-compliance to physician-recommended treatment. For example, a person may be prescribed a medication to take two tablets per day, or 60 tablets per month. If the plan has a quantity limit of 30 tablets per month for that medication, this will require the patient to contact the physician to get a refill, which could negatively impact or delay treatment.
- Non-Medication Switching, which occurs when, without the consent of the patient and the prescribing physician, the prescription is filled by a drug other than the one prescribed. In such cases, the health insurer requires a stable patient to switch from his or her current, effective medication to a less costly, alternative (but not generic) drug by removing the medication from the formulary list, moving a drug to a higher cost tier, or increasing the out-of-pocket costs owed. The Alliance for Patient Access has found that medication switching has resulted in higher patient costs. The American Heart Association and the American College of Cardiology oppose therapeutic substitution, believing that “only the prescribing doctor is equipped to determine the best drug or combination of drugs” and that therapeutic substitution “may result in the patient receiving a drug that doesn’t work well enough, produces life-threatening toxicity, or interacts dangerously with other drugs the patient is taking.”
- Formulary Exclusions, which are a list of drugs that will not be covered by health insurers or their pharmacy benefit managers except under specific clinical or regulatory circumstances.
According to a survey by the Doctor-Patient Rights Project, one in four patients reported being denied access to treatment coverage for a chronic or persistent illness and such denials are in the following proportions:
If you or your patient has been delayed or denied medications by a health insurer, we would like to hear your story. Please comment below.