Therapeutic substitution: Will it yield benefits for drug plan sponsors?

Therapeutic substitution is when a pharmacist dispenses a different drug than the one originally prescribed by a patient’s doctor. This could be because of an adverse interaction with drugs a patient is already taking, because another drug may offer a better outcome or because of the patient’s budgetary constraints.

Therapeutic substitution is not new; in the past, if the pharmacist felt the prescribed treatment was not appropriate or the patient couldn’t afford the drug prescribed, he or she would consult with the physician and the patient to dispense a different drug. What is new is that the legislation gives pharmacists the latitude to substitute a different medication without consulting the physician.

In provinces where pharmacists have been granted an expanded scope of practice, there are professional guidelines and ethics. For example, according to Sam Lanctin, registrar of the New Brunswick Pharmaceutical Society, “All pharmacists’ clinical decisions must be in the best interest of, and focus on the health needs of, the patient. Any indication that a decision is based on a benefit to the pharmacist or pharmacy rather than the patient may be considered unprofessional conduct.”

Around the time of these legislative changes, Medavie Blue Cross was renegotiating its pharmacy agreements across Atlantic Canada. Due to changing pharmacy business dynamics and reimbursement models—such as legislation in certain provinces preventing pharmacists from accepting professional allowances from drug companies and/or limiting the prices that can be charged for generics—pharmacies were looking to expand their service offerings and offer valued-added programs.

“Medavie Blue Cross was willing to work with pharmacies to demonstrate how additional pharmacist services could provide value to private drug plans,” Somers explains.

Several different pharmacy services were considered, and pilot programs were developed. A small group of pharmacies agreed to participate in the Medavie Blue Cross therapeutic substitution pilot, including Jean Coutu, a group of independent pharmacy owners under the Guardian and Medicine Shop Group and Loblaws.

Although therapeutic substitution can be done for many reasons, Medavie Blue Cross is not recommending which drugs should be switched—the pilot will simply monitor situations where a lower-cost drug is substituted. As the pharmacist’s expanded scope of practice allows, if—in his or her professional opinion—a lower-cost drug can be dispensed, he or she will follow normal professional protocol. A therapeutic substitution can result in a switch between two brand name drugs or between two generic drugs. It can also mean a switch from brand to generic or even sometimes from generic to brand. The option to switch to another medication is voluntary for plan members and does not change the way their claims will be reimbursed by Medavie Blue Cross.

“My regular patients love the fact that pharmacists can make a therapeutic substitution, because they no longer have to return to their doctor’s office for a new prescription.” – Dennis Abud, Jean Coutu Pharmacy franchisee

Medavie Blue Cross understands that there will be added administrative expenses to the pharmacies to participate in the pilot (e.g., sending Medavie Blue Cross the drug identification number of the original drug that was therapeutically substituted). To offset the administrative costs for pharmacies to participate, Medavie Blue Cross is compensating pharmacies with a nominal sum. However, Medavie Blue Cross has stressed to all pharmacies that this is not a fee for therapeutically substituting, but merely compensation for the expenses incurred by participation in the pilot.

“Medavie has full confidence that any decision by a pharmacist to therapeutically substitute will be done with the patient’s healthcare as the primary and paramount concern,” says Somers. “Remuneration for therapeutic substitution, if and when it were to happen from a payer to a prescriber, is secondary and mutually exclusive of the independent decision-making process of the prescriber, who, in this case, is a pharmacist. The determination of a fee for service will only be able to be determined once the pilot is finished and sufficient data exist that a fair value can be established for both pharmacy and Medavie Blue Cross plan sponsors.”

Dennis Abud, a Jean Coutu Pharmacy franchisee in Dieppe, N.B., and the past president of the New Brunswick Pharmacists’ Association, is participating in the pilot. “My regular patients love the fact that pharmacists can make a therapeutic substitution, because they no longer have to return to their doctor’s office for a new prescription,” he says. “This is an opportunity for pharmacists to use their professional judgment.” However, he also cautions that “we would only recommend alternatives for patients for whom we know their pharmaceutical history. We would also not make recommendations for therapeutic areas where we do not have the necessary lab values (e.g., cholesterol, blood sugar) to make a proper assessment.”

Plan sponsors that are feeling the pressure of drug plan cost increases are keen to see the results of the pilot. Ken MacDermid, manager of payroll, benefits and information management for Capital Health in Halifax, manages a drug plan for two healthcare sector unions, and although they have faced overall budget decreases, their drug plan costs continue to rise. “Because our benefits are collectively bargained, we do not have the flexibility to make plan design changes that are not negotiated,” explains MacDermid. “The therapeutic substitution program offers an opportunity to save on drug plan costs without changing plan design, and participation is voluntary for plan members.”

Dr. Matthew Burnstein, chief medical officer for Bell Aliant in Halifax, indicates that, as a physician, he is familiar with the concept of therapeutic substitution. “It is not uncommon to get a call from a pharmacist to recommend a therapeutic alternative for a patient,” he says. “This program is an innovative way for all stakeholders to contribute to the ongoing sustainability of the drug plan.”

According to Somers, the main objective of the pilot is to track therapeutic substitutions so that Medavie Blue Cross and pharmacies can assess the impact and value of the program for Medavie Blue Cross’s clients, private drug plan sponsors. Since there is little Canadian evidence to evaluate the impact of therapeutic substitution on private drug plans, the data captured during this pilot will allow Medavie Blue Cross to assess whether there is clinical and financial value for its plan sponsors, and whether it should develop a product offering for all of its clients.

A preliminary analysis will be done early in the new year, and results will be shared with the participants and other stakeholders. Some modifications may be made as a result of the interim analysis; however, a definitive end date for the pilot will probably be later in 2012.

Suzanne Lepage is a private health plan strategist from Kitchener, Ont.