Memorandum in Opposition

For Immediate Release:  January 13, 2023

Re: S.1267 (Breslin)/A.901 (McDonald) — AN ACT to amend the insurance law and the public health law, in relation to requiring a utilization review agent follow certain rules when establishing a step therapy protocol

The New York Health Plan Association opposes this legislation, S.1267/A.901, which would place significant restrictions health plans’ step therapy protocols, undermining quality and leading to higher costs for consumers and employers.

Step Therapy Protects Patients from Harm. Health plans use step therapy to promote quality and efficacy.  Many drugs have harmful side effects or interact adversely with other medications and step therapy encourages trying safer, alternative therapies first. Drugs with a high risk of abuse or overuse, such as powerful pain medications or antipsychotics, are good candidates for step therapy to encourage the use of safer, first-line medically appropriate therapies. Step therapy ensures that doctors consider medically appropriate alternatives before settling on a course of therapy for a specific patient, which can improve quality of care for a patient on multiples medications.

In addition to ensuring quality and protecting patients, health plans use step therapy policies to control rising prescription drug costs.  Restricting step therapy would mean increased costs for consumers and employers – both in higher premiums to account for overall increases in drug costs and in higher co-payments and out-of-pocket costs for more expensive drugs.

Step Therapy is Used for a Limited Number of Conditions.  Step therapy requires patients to try a medically appropriate first-line drug, typically a generic alternative to a branded product, when a new therapy is initiated.  By starting with a medication that has been available for the longest period of time, with known risks and outcomes, before moving on to newer and riskier or experimental drugs, health plans promote consumer access to proven effective drugs while keeping their out-of-pocket costs for those drugs as low as possible.

Step 1 drugs typically are generic drugs, which are approved only if they have the same high quality, strength, purity and stability as brand-name drugs and meet the same rigorous FDA standards.  If a generic option was tried and the patient did not achieve optimal outcome, the branded product is approved and dispensed.  Exceptions are permitted in instances in which a patient has already tried a different drug or can’t be prescribed a step 1 drug because it would be contraindicated with the patient’s other medications.  Step therapy is not used for life-threatening conditions and only applies to a limited number of conditions.

S.1267/A.901 is Unnecessary as Protections Already Exist for Patients & Providers.  Chapter 512 of the Laws of 2016 established strict requirements around step therapy protocols, providing additional protections for patients using step therapy protocols and creating an improved process for timely appeals and overrides of such protocols.  Plans are required to use evidence-based and peer-reviewed clinical criteria that also takes into account the needs of atypical patient populations when establishing step therapy protocols.  The law also provides a standardized appeals process to request an override determination where a prescriber does not believe the drug is in the best interest of the patient.  The process allows for an override where the prescriber demonstrates that the drug is likely to be ineffective based on the patient’s clinical history, or has been tried by the patient already and been ineffective, along with other reasons.

Ultimately, this legislation would increase risks to patients, and limits plans’ ability to negotiate better prices on prescription drugs, increasing costs for everyone.  For all these reasons, we OPPOSE S.1267/A.907.