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Volume 62, No. 3

22/2019

The British Columbia Gazette,

Part II

February 12, 2019

B.C. Reg. 22/2019 , deposited February 11, 2019, under the PHARMACEUTICAL SERVICES ACT [sections 62 and 65]. Order in Council 46/2019, approved and ordered February 11, 2019.

On the recommendation of the undersigned, the Lieutenant Governor, by and with the advice and consent of the Executive Council, orders that, effective April 1, 2019, the Drug Price Regulation, B.C. Reg. 344/2012, is amended as set out in the attached Schedule.

— A. DIX, Minister of Health ; S. SIMPSON, Presiding Member of the Executive Council .

Schedule

Section 1 (1) of the Drug Price Regulation, B.C. Reg. 344/2012, is amended

(

a) by repealing the

definitions of "designation period" and "exclusive generic drug" ,

(

b) by adding the following definition:

"generic drug inclusion or exclusion" means the inclusion of at least one additional generic drug in, or the exclusion of at least one generic drug from, an LCA category; , and

(

c) by repealing the definition of "manufacturer's list price" and substituting the following:

"manufacturer's list price" means the following:

(

a) in the case of an LCA category having an LCA drug comparator adopted from another jurisdiction under

section 3.01 (1) (a) [LCA drug comparators may be adopted from other jurisdictions] , the manufacturer's list price per unit of the adopted drug in that jurisdiction;

(

b) in any other case, the price per unit of a drug, as provided by a manufacturer to the minister in the manner and at the time required by the minister; .

Section 3 (2) is amended by adding the following paragraph:

(

d) despite paragraphs (

a) to (c), if

section 3.01 [LCA drug comparators may be adopted from other jurisdictions] applies, as described in that section.

3 The following

section is added:

LCA drug comparators may be adopted from other jurisdictions

3.01

(1) If, under subsection (2) of this section, this subsection applies to an LCA category established under

section 3 (1) (a), the minister may designate an LCA drug comparator for the category as follows:

(

a) by adopting as the LCA drug comparator a brand drug that is used by another jurisdiction of Canada as the reference drug to determine prices for a category of drugs, established in that jurisdiction, that is similar to the LCA category;

(

b) if the brand drug referred to in paragraph (

a) of this subsection is not on a formulary of British Columbia, or for any other reason, in accordance with

section 3 (2) (

a) to (c), as applicable.

(2) Subsection (1) applies to an LCA category as follows:

(

a) if the LCA category is established before April 1, 2014 and has no generic drug inclusions or exclusions before April 1, 2019, subsection (1) applies as of the date of the first generic drug inclusion or exclusion that occurs on or after April 1, 2019;

(

b) if the LCA category is established

(

i) before April 1, 2014 but has a generic drug inclusion or exclusion on or after April 1, 2014 but before April 1, 2019, or

(ii) on or after April 1, 2014 but before April 1, 2019,

subsection (1) applies as of the date of the first generic drug inclusion or exclusion that occurs on or after April 1, 2019, and causes the LCA category to move into a different tier as described in subsection (3);

(

c) if the LCA category is established on or after April 1, 2019, subsection (1) applies as of the date that the LCA category is established.

(3) For the purposes of subsection (2) (b), an LCA category moves into a different tier if any of the following occurs:

(

a) a category having only one generic drug has at least one more generic drug included in the category;

(

b) a category having only 2 generic drugs has

(

i) one generic drug excluded from the category such that only one generic drug remains in that category, or

(ii) at least one more generic drug included in the category;

(

c) a category having 3 or more generic drugs has generic drugs excluded from the category such that only one or 2 generic drugs remain in that category.

Section 3.1 is repealed.

Section 4 (2) is repealed and the following substituted:

(2) Except as set out in subsections (3) and (4), the maximum accepted list price for drugs in an LCA category that meets both of the following criteria is 25% of the manufacturer's list price for the LCA drug comparator for the LCA category, as of the date on which a generic drug is first included in or excluded from the category after April 1, 2019:

(

a) the LCA category consists of drugs available as oral solids only;

(

b) the LCA category was established

(

i) on or after April 1, 2019, or

(ii) before April 1, 2019, but has a generic drug inclusion or exclusion on or after April 1, 2019.

(2.1) Except as set out in subsections (3) and (4), the maximum accepted list price for drugs in an LCA category is the following percentage of the manufacturer's list price for the LCA drug comparator for that LCA category, as of the date on which a generic drug is first assigned to that LCA category:

(a) 20%, if the LCA category consists of drugs available as oral solids only but subsection (2) does not apply;

(b) 35%, in any other case.

Section 5 is amended

(

a) by repealing subsection (2) and substituting the following:

(2) Except as set out in subsection (3), the maximum accepted list price for drugs in an LCA category listed in Column 1 of the

Schedule is as follows:

(a) 25% of the base price set out in Column 2 of the

Schedule opposite the LCA category if the LCA category

(

i) consists of drugs available as oral solids only, and

(ii) has a generic drug inclusion or exclusion on or after April 1, 2019;

(b) 20% of the base price set out in Column 2 of the

Schedule opposite the LCA category if the LCA category consists of drugs available as oral solids only but paragraph (a) (ii) does not apply;

(c) 35% of the base price set out in Column 2 of the

Schedule opposite that LCA category in any other case. , and

(

b) in subsection (4) (

b) by striking out "

section 4 (2) " and substituting "

section 4 (2.1) ".

7 Sections 14 (1.1) (

a) and (3) and 15 (3) are repealed.

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