1Amending the act of May 17, 1921 (P.L.682, No.284), entitled "An
2act relating to insurance; amending, revising, and
3consolidating the law providing for the incorporation of
4insurance companies, and the regulation, supervision, and
5protection of home and foreign insurance companies, Lloyds
6associations, reciprocal and inter-insurance exchanges, and
7fire insurance rating bureaus, and the regulation and
8supervision of insurance carried by such companies,
9associations, and exchanges, including insurance carried by
10the State Workmen's Insurance Fund; providing penalties; and
11repealing existing laws," in casualty insurance, providing
12for pharmaceutical coverage for oral anticancer medications.

13The General Assembly finds and declares as follows:

14(1) Cancer treatment through chemotherapy has changed
15over time. Traditional anticancer medications are primarily
16administered intravenously. Intravenous chemotherapy tends to
17attack both cancerous and healthy cells alike.

18(2) More recently, there has been an increase in the
19development of orally administered anticancer medications
20that target only cancer cells and have fewer side effects
21than intravenous chemotherapy. Orally administered anticancer

1medications are also more convenient for patients and their
2caregivers and often allow patients to reenter the work force
3with minimal time lost for cancer care.

4(3) Improvements in cancer treatment are contributing to
5increased survival rates across all forms of cancer and
6decreased side effects and allow patients to continue to
7participate in most life activities.

8(4) Research has found that more than 25% of all
9anticancer agents currently in development are planned as
10oral medications. In early trials many of these new oral
11medications have shown significant clinical advantages over
12traditional intravenous and injected forms of cancer
13medications.

14(5) Intravenous anticancer medications are typically
15covered under a health plan's medical benefit, often
16requiring patients to pay a minimal, fixed copayment or pay
17no cost for the medication.

18(6) Orally administered anticancer medications are
19covered under a health plan's pharmacy benefit. Under the
20pharmacy benefit, orally administered anticancer medications
21are placed on the highest (specialty) tier of a health plan's
22cost-sharing system.

23(7) Typically, patients who receive orally administered
24anticancer medications must pay coinsurance rates of 20% to
2530% and, at times, rates as high as 50% in a specialty tier,
26resulting in extremely high and unmanageable out-of-pocket
27costs. These costs create an enormous barrier for patients to
28access orally administered anticancer medications prescribed
29for their treatment.

30(8) Increases in out-of-pocket costs of orally

1administered anticancer medications are associated with a
2corresponding decrease in adherence to treatment, further
3risking patient health and making treatment longer, more
4expensive and less effective.

5(9) It is estimated that 10% of cancer patients fail to
6fill their initial prescriptions for orally administered
7anticancer medications due to high out-of-pocket costs, and
825% of cancer patients delay initiating an alternative
9treatment. Further, research demonstrates that patients
10reduce their recommended doses of orally administered
11anticancer medications to avoid paying for medication
12refills. These behaviors negatively impact the effectiveness
13of orally administered anticancer medications.

14(10) The disparity in out-of-pocket costs negatively
15impacts patient adherence to their medication regimens and
16forces physicians to make decisions based on health plan
17benefit design rather than the most effective treatment for a
18patient.

19(11) An increasing number of cancer patients are
20reporting that they cannot afford the out-of-pocket cost for
21orally administered anticancer medication, yet need the
22medication as part of their prescribed treatment.

23(12) For many cancer patients, no intravenous
24chemotherapy substitute exists for their prescribed oral
25anticancer medication.

26The General Assembly of the Commonwealth of Pennsylvania
27hereby enacts as follows:

28Section 1. The act of May 17, 1921 (P.L.682, No.284), known
29as The Insurance Company Law of 1921, is amended by adding a
30section to read:

1Section 631.1. Pharmaceutical Coverage for Oral Anticancer
2Medications.--(a) Whenever an individual or group health,
3sickness or accident insurance policy or subscriber contract or
4certificate issued by any entity subject to 40 Pa.C.S. Ch. 61
5(relating to hospital plan corporations) or 63 (relating to
6professional health services plan corporations) or this act
7provides pharmaceutical coverage that includes coverage for
8cancer chemotherapy or anticancer medications which have been
9approved by the United States Food and Drug Administration for
10general use in the treatment of cancer, the policy shall not
11place orally administered anticancer medications on a specialty
12tier or charge a coinsurance payment for orally administered
13anticancer medications. The prohibition of coinsurance payments
14applies to charging a percentage of the cost of the medication
15or a flat-fee cost that is specific to anticancer medication,
16but does not include charging the minimal copayment that is
17usual for covered prescription medications not on a specialty
18tier.

19(b) Nothing in this section shall serve to diminish the
20benefits of any insured or subscriber in effect on the effective
21date of this section, nor prevent the offering or acceptance of
22benefits which exceed the minimum benefits required by this
23section.

24(c) This section shall apply to those insurance policies,
25subscriber contracts or certificates issued or entered into or
26renewed on or after the effective date of this section.

27(d) As used in this section:

28"Anticancer medication" means a drug or biologic that is used
29to kill, slow or prevent the growth of cancerous cells.

30"Specialty tier" means a formulary category for a

1prescription drug that meets one or more of the following
2criteria:

3(1) A high-cost medication that is used to treat and is
4prescribed for a person with a complex, chronic or rare medical
5condition.

6(2) The drug is not typically available at community retail
7pharmacies.

8(3) The drug requires special handling, storage or has
9distribution or inventory limitations.

10(4) The drug has a complex dosing regimen or requires
11special administration.

12(5) The drug is considered to have limited distribution by
13the United States Food and Drug Administration.

14(6) The drug requires complex and extended patient education
15or counseling, intensive monitoring or clinical oversight.

16(7) The drug has significant side effects or risk profile.

17Section 2. This act shall take effect immediately.