Definitions

1   (1) In this regulation:

"Act" means the Pharmaceutical Services Act;

"brand drug" means a drug

(a) for which the first notice of compliance has been issued under section C.08.004 or C.08.004.01 of the Food and Drug Regulations (Canada), C.R.C., c. 870, in respect of all 3 of the following:

(i) a particular active ingredient or combination of particular active ingredients;

(ii) strength;

(iii) dosage form, and

(b) that, before the issuance of any subsequent notice of compliance for another drug having the same active ingredient or combination of active ingredients, is or was marketed in Canada by

(i) the drug's innovator, or

(ii) a person acting under a licence granted by the drug's innovator;

"generic drug" means a drug having the same active ingredient or combination of active ingredients as a brand drug;

"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;

"high cost drug" means a high cost drug designated under section 7 (1) [high cost drugs];

"LCA category" means a category of drugs established under section 3 (1) (a) [LCA program];

"LCA drug comparator" means the drug designated under section 3 (1) (c) as the LCA drug comparator for an LCA category;

"LCA program" means the low cost alternative program under section 3;

"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;

"maximum accepted list price" means the maximum accepted list price as determined by the minister under section 3 (3);

"non-reference drug" means a drug, within a reference drug category, that has not been designated as a reference drug;

"oral solid" means a drug that

(a) is available in a solid form, including as a gel capsule, chewable tablet or wafer, and

(b) is intended to be taken orally;

"provisional drug" means a drug designated under section 14 (1) [designation of provisional drugs] as a provisional drug;

"reference drug" means a drug, within a reference drug category, designated under section 6 (2) (b) [reference drug program] as a reference drug;

"reference drug category" means a category of drugs listed in section 6 (1);

"reference drug comparator" means the drug designated under section 6 (2) (c) as the reference drug comparator for a reference drug category.

(2) Despite subsection (1), the minister may do one or both of the following for the purposes of the LCA program:

(a) deem a generic drug to be a brand drug;

(b) deem a brand drug to be a generic drug.

[am. B.C. Regs. 266/2016, Sch. 2, s. 1; 22/2019, s. 1.]

Application

2   This regulation applies only to drugs, except insulin, that are benefits under the Act.

Low cost alternative program

3   (1) For the purposes of the low cost alternative program, the minister

(a) may establish LCA categories consisting of drugs that have the same active ingredient or combination of active ingredients, and the same strength,

(b) may, for each category, determine which drugs are included, and

(c) may, for each category established on or after April 1, 2013, designate one drug as the LCA drug comparator.

(2) If the minister designates an LCA drug comparator, the minister must designate the LCA drug comparator as follows:

(a) if there is a single brand drug in an LCA category, that brand drug;

(b) if there is more than one brand drug in an LCA category, the brand drug that, in the opinion of the minister is the most cost-effective of the brand drugs in the category;

(c) if there are no brand drugs in an LCA category, the LCA drug comparator of another LCA category having drugs with the same active ingredient or combination of active ingredients, but a different strength, as the first LCA category;

(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 minister must determine the maximum accepted list price for the drugs in each LCA category in accordance with the following, as applicable:

(a) section 4 [LCA categories established on or after April 1, 2013];

(b) section 5 [LCA categories established before April 1, 2013].

(4) The minister may change or cancel a determination or designation made under this section, including cancelling the establishment of an LCA category.

(5) A change or cancellation under subsection (4) may be made at any time without notice to anyone or an opportunity to be heard.

(6) The minister must publish on the website of the ministry of the minister all of the following:

(a) a list of all LCA categories;

(b) for each LCA category, the maximum amount the minister may pay under the Act for a drug within the LCA category.

[am. B.C. Reg. 22/2019, s. 2.]

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.

[en. B.C. Reg. 22/2019, s. 3.]

Repealed

3.1   Repealed. [B.C. Reg. 22/2019, s. 4.]

Low cost alternative categories established on or after April 1, 2013

4   (1) This section applies to LCA categories established on or after April 1, 2013.

(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.

(3) If the manufacturer's list price of an LCA drug comparator decreased by more than 20% within 2 years before a generic drug is first assigned to the LCA category, the date for the purposes of subsection (2) is the date that is 2 years before a generic drug is first assigned to that LCA category.

(4) If section 3 (2) (c) [LCA program] applies, the maximum accepted list price for drugs in the LCA category having no brand drugs is proportional, depending on their strength, to the maximum accepted list price that applies to the LCA category to which the designated LCA drug comparator belongs.

[am. B.C. Regs. 344/2012, s. (d); 22/2019, s. 5.]

Low cost alternative categories established before April 1, 2013

5   (1) This section applies to LCA categories established before April 1, 2013.

(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.

(3) If a drug in an LCA category had, as of July 1, 2010, a lower manufacturer's list price than the maximum accepted list price calculated under subsection (2), the maximum accepted list price for drugs in the LCA category is the manufacturer's list price, as of July 1, 2010, of the lower priced drug.

(4) The minister may deem, at any time, an LCA category established before April 1, 2013, to have been established on or after April 1, 2013, in which case,

(a) the maximum accepted list price for drugs in the LCA category is to be determined in accordance with section 4 [LCA categories established on or after April 1, 2013], and

(b) for the purposes of section 4 (2.1), the date on which a generic drug is first assigned to the LCA category is deemed to be the date on which the minister deems the LCA category to have been established.

[am. B.C. Regs. 344/2012, s. (d); 22/2019, s. 6.]

Reference drug program

6   (1) The following are reference drug categories for the purposes of the reference drug program:

(a) angiotensin converting enzyme inhibitors;

(b) angiotensin receptor blockers;

(c) dihydropyridine calcium channel blockers;

(d) histamine-2 receptor antagonists;

(e) hydroxyl-3-methylglutaryl-coenzyme A reductase inhibitors;

(f) non-steroidal anti-inflammatory drugs;

(g) oral nitrates;

(h) proton pump inhibitors.

(2) The minister may, for each category,

(a) determine which drugs are included,

(b) designate one or more drugs as reference drugs, and

(c) designate one drug as the reference drug comparator.

(3) A drug may be designated as a reference drug if the minister is of the opinion that the drug is at least as clinically efficacious or cost-effective as other drugs in the reference drug category.

(4) The minister may designate any of the following as the reference drug comparator:

(a) the reference drug that, in the opinion of the minister, is the most cost-effective of the reference drugs in the reference drug category;

(b) the drug that was designated before April 1, 2013, as the reference drug comparator for the reference drug category;

(c) the drug, in the reference drug category, that, in the opinion of the minister, will best serve the public interest if designated as the reference drug comparator for the reference drug category.

(5) The minister must determine the daily therapeutic dose of the reference drug comparator, the daily therapeutic dose being

(a) the typical dose that is prescribed, and

(b) the number of doses that a beneficiary would typically receive each day.

(6) The minister may change or cancel a determination or designation made under this section.

(7) A change or cancellation under subsection (6) may be made at any time without notice to anyone or an opportunity to be heard.

(8) The minister must publish on the website of the ministry of the minister a list of all of the following for each reference drug category:

(a) the drugs that are included;

(b) the drugs that have been designated as reference drugs;

(c) the drug that has been designated as the reference drug comparator and the applicable daily therapeutic dose;

(d) the maximum daily amount the minister may pay under the Act for a non-reference drug, as determined under section 9 [maximum payment for non-reference drugs].

[am. B.C. Reg. 255/2015.]

High cost drugs

7   (1) The minister may designate a drug as a high cost drug if the minister determines that the maximum daily amount the minister may pay for the drug when averaged over a one-year period is equal to or greater than $40, having regard to the following factors:

(a) the maximum amount the minister would otherwise pay, as determined under section 11 [prices for other drugs], if the drug were not designated as a high cost drug;

(b) the typical dose that is prescribed;

(c) the number of doses that a beneficiary would typically receive each year.

(2) The minister must publish on the website of the ministry of the minister a list of all high cost drugs.

Minister must not pay more than maximum amount

8   The minister must not make a payment under the Act for a drug in an amount that is greater than provided for in this Division.

Maximum payment for non-reference drugs

9   (1) The maximum amount the minister may pay for a non-reference drug that is not subject to the LCA program is the lesser of

(a) the sum of the manufacturer's list price for the drug and 8% of that price, and

(b) the maximum daily amount the minister may pay for the reference drug comparator for the reference drug category to which the non-reference drug belongs, as if the reference drug comparator were being dispensed at the daily therapeutic dose determined under section 6 (5) [reference drug program].

(2) The maximum amount the minister may pay for a non-reference drug that is subject to the LCA program is the lesser of

(a) the amount determined under subsection (1), as if the non-reference drug were not subject to the LCA program, and

(b) either,

(i) if there are no provisional drugs in the LCA category to which the non-reference drug belongs, the sum of the maximum accepted list price for the LCA category to which the drug belongs and 8% of that price, or

(ii) if there are provisional drugs in the LCA category to which the non-reference drug belongs, the maximum amount the minister may pay for a drug under section 11 (4) [prices for other drugs].

Maximum payment for high cost drugs

10   (1) The maximum amount the minister may pay for a high cost drug that is not subject to the LCA program is the sum of the manufacturer's list price for the drug and 5% of that price.

(2) The maximum amount the minister may pay for a high cost drug that is subject to the LCA program is the lesser of

(a) the amount determined under subsection (1), as if the high cost drug were not subject to the LCA program, and

(b) the applicable amount from among the following:

(i) if, in the LCA category to which the high cost drug belongs, there are only high cost drugs and none are provisional drugs, the sum of the maximum accepted list price for the LCA category to which the drug belongs and 5% of that price;

(ii) if, in the LCA category to which the high cost drug belongs, there are one or more drugs that are not high cost drugs but there are no provisional drugs, the sum of the maximum accepted list price for the LCA category to which the drug belongs and 8% of that price;

(iii) if, in the LCA category to which the high cost drug belongs, there are one or more provisional drugs, the maximum amount the minister may pay for a drug under section 11 (4) [prices for other drugs].

Prices for other drugs

11   (1) This section applies to drugs other than non-reference drugs and high cost drugs.

(2) The maximum amount the minister may pay for a drug that is not subject to the LCA program is the sum of the manufacturer's list price for the drug and 8% of that price.

(3) The maximum amount the minister may pay for a drug that is subject to the LCA program and is in an LCA category having no provisional drugs is the lesser of

(a) the sum of the maximum accepted list price for the LCA category to which the drug belongs and 8% of that price, and

(b) the sum of the manufacturer's list price for the drug and 8% of that price.

(4) The maximum amount the minister may pay for a drug that is subject to the LCA program and is in an LCA category having one or more provisional drugs is the sum of the manufacturer's list price for the highest-priced provisional drug and

(a) 8% of that price if the provisional drug is not a high cost drug, or

(b) 5% of that price if the provisional drug is a high cost drug.

(5) Despite subsections (2) to (4) of this section, if an agreement under section 20 (2) [price regulation] of the Act includes a term respecting the price of a drug, the maximum amount the minister may pay for the drug is the agreed price.

Price if unanticipated drug shortage

12   (1) This section applies to

(a) a brand drug within an LCA category having an insufficient supply of drugs as described in section 16 (1) [temporary listing of drugs], and

(b) a drug that is temporarily listed under section 16 (2).

(2) If section 16 (1) applies, despite sections 9 [maximum payment for non-reference drugs] to 11 [prices for other drugs], the maximum amount the minister may pay for a drug referred to in subsection (1) of this section during the period of unanticipated shortage is as follows:

(a) if the drug is a non-reference drug, the lesser of

(i) the sum of the manufacturer's list price for the drug and 8% of that price, and

(ii) the maximum daily amount the minister may pay for the reference drug comparator for the reference drug category to which the non-reference drug belongs, as if the reference drug comparator were being dispensed at the daily therapeutic dose determined under section 6 (5) [reference drug program];

(b) if the drug is a high cost drug, the sum of the manufacturer's list price for the drug and 5% of that price;

(c) in any other case, the sum of the manufacturer's list price for the drug and 8% of that price.

Price if inter-jurisdictional agreement applies

13   If the government of British Columbia is a party, with the government of one or more other jurisdictions, to an agreement, a memorandum of understanding or another similar arrangement that is designed to provide for a supply of drugs at a price that is lower than the maximum amount the minister would otherwise pay under this Division,

(a) sections 9 [maximum payment for non-reference drugs] to 12 [price if unanticipated drug shortage] do not apply, and

(b) the maximum amount the minister may pay for a drug affected by the agreement, memorandum of understanding or arrangement is the amount resulting from the implementation of the agreement, memorandum of understanding or arrangement.

Designation of provisional drugs

14   (1) The minister may designate a generic drug as a provisional drug if any of the following circumstances apply:

(a) the minister is of the opinion that

(i) there will be an insufficient supply of drugs within an LCA category, and

(ii) listing the drug on a formulary is necessary to ensure a sufficient supply of drugs within the LCA category to which the drug is or would be assigned;

(b) the drug could otherwise not be listed on a formulary under section 15 (2) (a) [minister not to list certain generic drugs], but an agreement under section 20 (2) [price regulation] of the Act includes a term respecting the price of the drug;

(c) the minister is of the opinion that listing the drug on a formulary is in the public interest.

(1.1) A generic drug's designation as a provisional drug is cancelled as follows:

(a) Repealed. [B.C. Reg. 22/2019, s. 7.]

(b) if the circumstances referred to in subsection (1) (a), (b) and (c) no longer apply, the minister may, at any time, cancel a designation made under this section in respect of any generic drug.

(2) The minister may cancel a designation made under this section without notice to anyone or an opportunity to be heard.

(3) Repealed. [B.C. Reg. 22/2019, s. 7.]

[am. B.C. Regs. 266/2016, Sch. 2, s. 3; 22/2019, s. 7.]

Minister not to list certain generic drugs

15   (1) This section applies to a generic drug that is or would be assigned to an LCA category, but does not apply to a generic drug that is

(a) a provisional drug, or

(b) the subject of a term of an agreement, a memorandum of understanding or another arrangement under section 13 [price if inter-jurisdictional agreement applies].

(2) The minister must refuse to list on a formulary a drug described in subsection (1), or must cancel the listing on a formulary of a drug described in subsection (1), if either of the following circumstances applies:

(a) the manufacturer's list price for the drug is higher than the maximum accepted list price for the LCA category to which the drug is or would be assigned;

(b) the manufacturer of the drug fails to supply information satisfactory to the minister respecting the drug within the time required by the minister.

(3) Repealed. [B.C. Reg. 22/2019, s. 7.]

[am. B.C. Regs. 266/2016, Sch. 2, s. 4; 22/2019, s. 7.]

Temporary listing of drugs

16   (1) This section applies if the minister

(a) is of the opinion that there is, or there is about to be, an insufficient supply of drugs within an LCA category, and

(b) could not reasonably have anticipated the insufficient supply.

(2) Despite any other provision of this Part, the minister may list on a formulary, for the purpose of ensuring a sufficient supply of drugs within an LCA category, a drug that could not otherwise be listed.

(3) The minister must cancel the listing of the drug when the minister is of the opinion that the period of unanticipated shortage has ended.

Repealed

17   Repealed. [B.C. Reg. 266/2016, Sch. 2, s. 5.]