By Dennis McNannay, Oregon Bioscience Association Executive Director, and Dianne Danowski Smith, Oregon Bio board member
Oregon Bioscience Association marches on in its expanding mission as the leading voice of the bioscience industry in Oregon. We accomplish this by promoting industry collaboration/networking, offering workforce training and education, guiding effective advocacy programs and positions, and cultivating industry growth through proactive strategic planning and economic development.
As a trade association, Oregon Bio has done important work on public policy that affects commercialization; market access; industry impact and investments; and economic development. The association’s work has elevated its brand across all levels of the political spectrum in Oregon. Legislators are both better educated about the industry and more aware of the economic impact bioscience has had on their various districts. Below are some of Oregon Bio’s more recent accomplishments:
• Passage of the Oregon Investment Act
• Extended Oregon research and development tax credits
• Passage of biosimilars bill
• Appropriation of BioCatalyst funding
• Continued funding of OTRADI and the incubator
In 2014, the Oregon Bio board of directors set forth three rotational, yearly strategic priorities (Educate, Advocate and Cultivate) to create a clear focus and special attention on a single element of our organization mission each year. For example, in 2014 the Oregon Bio team focused on education and workforce training as its strategic priority. These focused efforts led to the successful implementation of the Business Oregon-sponsored BioCatalyst program and the introduction of several new BioPro programs. For 2015, the strategic priority is Advocacy.
Says Jennifer Stoll, board member and chair of Oregon Bio’s Government Affairs and Advocacy Committee (GAAC), “Though always an ongoing priority and one of the three central value propositions for Oregon Bio, advocacy is here and now. In anticipation, our advocacy efforts play upon key goals, objectives, activities, resources and deployment schedules to guide our 2015 legislative agenda.”
For more information and updates on the Oregon Bio’s key legislative issues in the 2015 session, watch www.oregonbio.org/policy/
OR Bio legislative policy issues for 2015
In outlining the key issues, there are specific policy topics emerging in the 2015 state legislature that Oregon Bio’s advocacy committee is tracking. In some cases, these issues are continuing from previous legislative sessions and require modification or updating, while other issues will be new issues we expect to emerge. These include but are not limited to:
1. SBIR and STTR matching: Oregon Bio has been working on the development of a matching program for Oregon companies and institutions receiving Small Business Innovation Research (SBIR) and Small Business Technology Transfer Research (STTR) monies. This can expand the bioscience industry beyond incubation. The primary effort will be to support Business Oregon’s budget request for SBIR-matching grants and work with the agency to develop criteria. The longer-term goal is to develop a roadmap for an Oregon “BioMatch Fund” and secure more meaningful funding in the future.
BioMatch is a proposed two-year pilot bioscience-specific state matching fund (BioMatch), which would provide staged funding to support the commercialization activities of small companies that have been awarded SBIR grants.
The BioMatch fund proposal is a direct response to the “capital gaps” identified in the 2012 Capital Scan report which are likely to be magnified in future years based on the volume of research anticipated from the Knight Cancer Institute and other Oregon research institutions. In 2014, Oregon Bio sought project development funds from key development partners to complete – and formally present during the 2015 legislature – actionable plans for establishing the governance, administration, operational guidelines and ROI/outcomes measurement guidelines of the eventual BioMatch fund.
Preliminary Oregon Bio fact finding reveals that similar state matching fund programs have proven to be very powerful, effective, low risk and affordable economic development initiatives, yielding a sustainable return in the form of high wage job creation, accelerated company formation, and powerful company recruitment incentive for state economic development. The placeholder bill has not yet been drafted or introduced. Oregon Bio will continue to broker a public/private partnership to fund a more definitive study evaluating the funding needs for Oregon’s bioscience industry.
2. Pharmacy synchronization: In 2014, several Oregon Bio member organizations supported the passage of Senate Bill 1579. This legislation allowed patients in managed Medicaid health plans to synchronize their medication refills all on a certain day during the month/or cycle, or according to the patient’s health plan. The new law allows half or portioned refills to be authorized to bring all the refill dates together as one, making a way for health plans in Oregon to both uniformly implement the policy, and to cover partial refills in accordance with the patient’s current prescription drug plan/benefits.
Synchronization builds upon two successful and emerging models of care that are already widely adopted in Oregon: The Appointment-Based Model and the Patient-Centered Medical Home. Both models engage the patient in a more meaningful way using the Triple Aim to improve quality and patient experience. The bill set out to:
• Improve patient education, adherence and compliance by engaging the patient more closely with his his/her health care provider for more optimum and coordinated care.
• Reduce time and worry for patients who are managing one or a multiple medication regimen.
• Reduce duplicative interactions between pharmacists and physicians by creating a “one-stop” authorization and dispensing process.
• Minimize the need for unplanned provider intervention in potential cases of negative medication interactions or improper patient dosing, and
• Create more efficiencies and a checks-and-balances system with providers in tracking, charting and monitoring patients’ medication usage and refill status.
The 2015 follow-on bill extends these benefits to those with commercial and private pay insurance to allow prescriptions to be automatically refilled on the same day each month and to align refill dates of recurring prescriptions. Specific legislative language has not yet been introduced, but it aims to expand the 2014 session’s SB 1579.
3. Biosimilars: These are products that are highly similar to biologic drugs that are already Food and Drug Administration (FDA)-approved. The term “biosimilar” is not synonymous with “generic,” however. The Patient Protection and Affordable Care Act amends the Public Health Service Act to create an abbreviated licensure pathway for biological products that are demonstrated to be “biosimilar” to or “interchangeable” with an FDA-licensed biological product. This pathway is provided in the part of the law known as the Biologics Price Competition and Innovation Act (BPCI). Under the BPCI Act, a biological product may be demonstrated to be “biosimilar” if data show that, among other things, the product is “highly similar” to an already-approved biological product.
In the 2013 legislative session, Oregon Bio supported successful passage of a bill that allowed for the substitution by a pharmacist of “interchangeable” biosimilar medicines approved by the FDA. The process adopted is very similar to the process currently used under Oregon law by pharmacists when substituting FDA-approved generic medicines.
The 2013 legislation included a requirement that the pharmacist notify the prescriber (after dispensing) when an “interchangeable” biosimilar is substituted for the brand biologic medicine. This requirement is set to expire in January 2016, just as the FDA is set to approve the first U.S. biosimilars. Currently, three manufacturers have made applications to the FDA for biosimilar approval which is anticipated in 2015.
Oregon Bio supports legislation in 2015 specifying that a dispensing pharmacist must communicate to the prescriber the specific biologic medicine dispensed (the interchangeable biosimilar or brand biologic) in order to maintain accurate patient records, utilizing electronic technology wherever possible. Opposition is anticipated from health plans and practitioners.
4. Right to try: This is perhaps among the most controversial legislation to be potentially introduced this session. Under Legislative Concept 1942, this bill could allow an attending physician to prescribe non-FDA-approved drugs to terminally ill patients, if the patient is over the age of 18 and an Oregon resident.
Similar bills have been enacted in 2014 in Arizona, Colorado, Louisiana and Missouri. However, industry leaders are concerned about the overall concept of the Oregon bill, as it is fraught with what could potentially be many unintended consequences.
This legislation raises myriad ethical and legal concerns for manufacturers and potentially short circuits the safety of the FDA approval and testing process. As currently written, the bill contains no legal or liability protections for manufacturers. Oregon Bio has not taken a position on the bill. The legislation has been filed pre-session and is sponsored by House Health Care Committee.
5. Cap the copay: While the Affordable Care Act established annual out-of-pocket caps (up to $6,600 for an individual and $13,200 for a family in 2015), many patients still cannot afford their health plan’s monthly costs associated with chronic disease management. Often, insurers put medicines for chronic and complex illnesses into a tiered-cost structure, so common medicines for diseases or conditions such as cancer, arthritis, diabetes, HIV, multiple sclerosis, lupus, etc., require higher co-insurance or co-pays from the consumer.
Studies show high cost-sharing has been shown to lower medication adherence, a problem estimated to cost $290 billion annually. On average, a $10 increase in co-pays yields a 4 percent increase in non-adherence.
A broad-based coalition of several patient advocacy groups has come together to address escalating consumers’ out-of-pocket costs for their prescriptions by launching a “Cap the Copay” legislative effort. The draft legislative concept seeks to limit a patient’s copayment or coinsurance to not exceed $100 per month for each prescription drug up to a 30-day supply of any single drug. The legislation also limits both what a patient pays in co-insurance and co-pays pre-deductible, and prohibits health plans from placing all drugs in a given class on the highest cost tier.
6. Other issues: Other legislative concepts and efforts that may concern Oregon Bio members are also being closely monitored. These may include, but are not limited to potential GMO labeling requirement proposals; repealing mental-health carve out for the Practitioner-Managed Prescription Drug Plans; monitoring any changes to rules and decisions of the Health Evidence Review Commission; and supporting the regional solutions budget to facilitate OTRADI expansion in Central Oregon.
How Oregon Bio members can help with advocacy
The success of Oregon Bio’s policy efforts in 2015, as with times past, is the engagement of members. Oregon Bio members are encouraged to join and support the government affairs and advocacy efforts in both large and small ways. Watch Oregon Bio’s website, its weekly E-blast and its quarterly newsletter for ongoing news and developments. The GAAC will work to keep Oregon Bio’s members apprised of legislative and advocacy issues.
Dennis McNannay is Executive Director of the Oregon Bioscience Association
Dianne Danowski Smith, APR, Fellow PRSA serves on the board of directors of Oregon Bio, as well as the boards of the Beaverton Area Chamber of Commerce and Project Access NOW. She is a public affairs and health policy consultant working on local and statewide issues relating to industry growth and public health access.