Elections, budget woes and health care discourse are expected to drive a full policy agenda in state legislatures across the country in 2016. The Astellas Government Affairs team anticipates three priority areas will be critical to protecting patient access to care.
Access to Care for Seriously Ill Patients
In 2013, Oregon’s Health Evidence Review Commission adopted Revised Guideline 12, which limits access to cancer treatments based on the severity of an individual’s medical condition and his or her life expectancy. In other words, it potentially allows for the most vulnerable patients to be denied treatment. While Guideline 12 is specific to Medicaid patients in Oregon living with terminal cancer, it creates the potential for such action to be expanded to include other serious diagnoses like cardiovascular and cerebrovascular conditions.
Access to Care laws – also known as Right to Treatment laws – are intended to prevent restricted access to medicines. However, at the time of this publication, only four states (Mississippi, Louisiana, Georgia and Utah) have laws in place to ensure unrestricted access to medicines for those with a serious or terminal diagnosis. Astellas Government Affairs is actively engaged on this issue in several states throughout the country.
In 2016 we anticipate seeking regulatory or legislative solutions that will ensure patients can get access to prescribed treatments regardless of their diagnosis with a terminal condition.
Step therapy, also known as “fail first,” is a method insurers use to control costs, but may delay access to the most appropriate treatment for a patient as determined by his/her physician. The step therapy process takes the decision-making authority regarding treatment away from the patient and his or her health care professional and puts it in the hands of the insurer. Limiting step therapy protocols or calling for a simplified exemption process on behalf of providers and patients would improve patient access to therapies considered standard of care for some of the most challenging clinical conditions.
The Astellas Government Affairs team is working to introduce legislation or regulatory solutions that protect patients from the potentially negative impacts of this practice.
To date, 18 states have passed some form of legislation to regulate the use of step therapy. Astellas is working on this issue to protect patients in several other states.
Patient Pathway Protections
In an effort to more closely manage costs, insurers are increasingly adopting clinical pathway programs to steer providers and beneficiaries to treatment options. However, these pathways may not always be in the best interest of the patient and may not take into consideration the patient’s individual health needs.
Clinical pathways detail essential steps in patient care with the goal of improving patient outcomes and clinical efficiency. Many clinical pathways are developed at the local or institutional level by the providers who are expected to implement them – an approach that strives to ensure the unique needs of patients are met by taking into account variations in the way medicine is practiced within local communities.
In some cases, however, payers are developing their own clinical pathways rather than accepting the clinical pathways developed and recognized within the relevant medical community. As these payer pathways become more prevalent, it will be essential to ensure standards are established to include appropriate clinical evidence and processes for the use of payer-designed clinical pathways.
In 2016, Astellas Government Affairs will advocate for legislation or regulatory solutions that require provider and professional community input in the development of treatment pathways.
Astellas Government Affairs looks forward to continuing its work with industry partners, advocacy organizations, and others to assure patients have access to potentially life-saving drugs and the information they need to make decisions related to their care.